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Recent 510k Clearances Inquiries

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Medical Device

I need a 510k for a device. I believe it would be abbreviated since its already in the market, just a different brand.

  1. Profile Picture

    Monther |Sr. Manager

    Hi, I'll be glad to assist you with your 510(k) submission. But the question I have is a submission ...

    4 Minutes Later
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    Jim |Principal

    i'd be happy to help...

    13 Minutes Later
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    Al |Founder and Consultant

    510(k)s are not only market clearance submissions but they can establish a valuable *****e...

    27 Minutes Later
+38 Other Responses
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Fda 510k

We are looking for partners in us who take care of fda c-1,2,3 and 510k and clinical trial. We have many customers who need the services. If of interest please contact me via zintro.

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    Ana Maria Saaibi |Director of Regulatory Affairs

    Hi, We are a consulting company with more than 7 years of experience in *****irs for medic...

    2.8 Hours Later
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    Cynthia |Regulatory Affairs Consultant

    Hello, I am an independent consultant specializing in class II 510(k) submissions. Please contact m...

    6.3 Hours Later
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    Courtland |CEO

    Please let us know how we can assist you. Our firm is celebrating 11 years. Our average age in i...

    6.6 Hours Later
+14 Other Responses
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Fda Compliance

Need a special 510k filed with all the proper tests for our implantable medical device? Immediate need!

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    New |

    Hello, I was a study director for long-term implantable products and handled ***** (in-v...

    2.6 Hours Later
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    Prabodh |Sr Manager R&D

    I have over 25 years experience in medical devices. I have experience in the areas of FDA and CE reg...

    2.8 Hours Later
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    James |CEO

    To Whom it May Concern, I have over 15 years of 510(k) experience. I am a former reviewer for the ...

    2.8 Hours Later
+21 Other Responses
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Medical Device Approval

Regulatory affairs personnel needed be a link between our company and fda. We have an ophthalmoscope, which needs 510k approval and would like someone to help us through this process. Key duties of the job include: • communicating with regulatory authorities • gathering, evaluating, organizing, managing and collecting information in a variety of formats • ensuring compliance with the 510k standards • keeping up-to-date with changes in regulatory legislation and guidelines • analyzing complicated information, including trial data • outlining requirements for labeling, storage and packaging • ensuring that quality standards are met and submissions meet strict deadlines • preparing documentation.

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    Robert |Zintro Expert

    Hi, I would be very happy to help with 510k and other FDA *****vities. I recently left a de...

    1.6 Hours Later
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    David |Zintro Expert

    I would love to help you but currently, I can only assist remotely...

    1.6 Hours Later
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    Les |Principal

    Good morning, I can definitely provide you with the services you require. With more than 40 years ...

    1.7 Hours Later
+58 Other Responses
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Medical Device 510k

We are a contract manufacturing company. We have a medical device manufacturing license from the state of california. We manufacture private label personal lubricants that now require 510k approval by the fda. Our customer that we manufacture the lubricants for has gotten 510k approval on his product, but that is only for his brand. As a contract manufacturer we must get 510k approval on our formula and list what brands we produce it under. I need a consultant that has 510k experiences.

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    Parul |Regulatory Consultant, Elexes Inc.

    I have done successful 510k submissions, and would love to do this job for you! Why am I a good fi...

    22 Minutes Later
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    steve |ceo

    HI, Happy to get your *****red through the 510k process. I and my small team have gotten ...

    25 Minutes Later
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    Timothy |Principal

    I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...

    33 Minutes Later
+35 Other Responses
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510k Premarket Notification

I'm looking for someone who can guide me on the process for submitting a 510(k) premarket notification for a class 2 medical device.

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    Christopher |Principal Consultant

    Hi, we have submitted and cleared many class II devices. Please send me an email and we can set up ...

    2 Minutes Later
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    Monther |Sr. Manager

    Hi, I'll be glad to assist you with your 510(k) submission. M.Abushaban...

    4 Minutes Later
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    Lisa |President/CEO

    I would like the opportunity to assist you with the process of filing a 510k for a Class 2 medical d...

    16 Minutes Later
+21 Other Responses
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510(k) Submission On Medical Device

We are under serious time constraints on our special 510k filing for a medical device. I have all the paperwork and test loosely together and ready to organize and submit to the fda. If you can help: - are you available to begin immediately - what is the estimated time to submission, assuming all data is received by you? I am ready to move forward immediately. Thank you

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    New |

    Subject: 510(k) Project for Medical Devices Yes, I can assist you till final *****ide ...

    1.6 Hours Later
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    Umberto |Previously: COO, VP & Director Regulator

    Dear. Inquirer, I have a great deal of experience in this area and can help. Please let me know m...

    4.9 Hours Later
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    EE BIN |

    Hi there, our team has done a special K prior and should have the expertise to help. what kind of de...

    5.7 Hours Later
+48 Other Responses
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Wound Care Medical Device

Subject -- wound care medical device 510k / pma hi all, we are looking for expert who has done a wound care 510k or pma submission this year or last year. We are looking for a long term engagement. We do not need help writing the submission, but we only need advise on deciding what claims we can make or not make, what type of concerns fda has expressed in the recent submissions, and will the product be subject to a 510k or a pma submission. Please do let us know your hourly rate. Thank you! jasmine

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    Courtland |CEO

    Jasmine, Our team has a wound care expert. 33 years experience. Many submissions and product deve...

    4.8 Hours Later
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    steve |ceo

    Hi Jasmine, We have a number of long term clients, start-up and well established companies to who we...

    4.9 Hours Later
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    Michael |Regulatory Project Manager

    Hi Jasmine, *****irs Associates (RAA) has successfully submitted over 200 medical device s...

    5.1 Hours Later
+13 Other Responses
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510k Approval

Hi. Our company is developing a dental laser and seeking 510k approval. We have used a third party reviewer and 510k submission was sent 2 weeks ago. Last week, we received a response with some deficiencies which are not in line with 510k guidance document and making the proper response somewhat difficult. We have in the past developed and submitted 510k for the exact same product without any challenges. The new 510k combines features of past cleared 510k devices and are substantially equivalent to our product . We submitted 510k with 1 primary and 2 secondary predicate devices. In their response to us fda is ignoring both secondary predicates and we must prof substantial equivalence with the primary alone. The fda guidance document on the preparation of 510k's clearly states that multiple predicates can be used when combining features of multiple devices into 1 device. Our product combines features of primary and secondary predicates. The fda is asking us to prove substantial equivalency with the primary predicate alone which we don't believe to be an issue. What triggered us to reach assistance is the fact that fda is also asking for animal study to prove substantial equivalency. It is important to disclose that primary predicate have submitted animal study in their submission. We would like to have a conference call if possible, explain more in detail about our product submission, product and share with you the 510k deficiency report in order to seek guidance on how to proper respond back to them.

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    Hrishikesh |Consultant

    Would be more than happy to answer any questions and I would not mind discussing your issues at no c...

    23 Minutes Later
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    Jasmine |Zintro Expert

    Hi, Yes you can use multiple predicates, only thing is that using each of the predicates, independen...

    28 Minutes Later
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    James |CEO

    To Whom it May Concern: I have served as a Third Party reviewer for the FDA and am currently in pri...

    32 Minutes Later
+13 Other Responses
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510(k) Clearance

I'm doing a 510k and would like someone to review before i submit.

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    Shelly |General Partner, Eureka! Bioscience and

    The FourCe, LLC is experienced with 510k's production and review. Contact us today to discuss how w...

    7 Minutes Later
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    Michael |Regulatory Project Manager

    *****irs Associates (RAA) is a premier *****ulting firm. We have successfully s...

    17.3 Hours Later
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    Parul |Regulatory Consultant, Elexes Inc.

    The most important elements for obtaining a timely FDA clearance is having the right Predicate, prop...

    17.8 Hours Later
+14 Other Responses
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Medical Device Approval

Medical device approval we are looking to generate a series of independent predicate recommendations for an anaesthesia system being developed prior to filing for a 510k with fda.

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    Jim |Principal

    I may be able to help with this....

    1 Hour Later
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    John |Director of anesthesia

    As an anesthesiologist With experience in Medical device, I can help. Please let me know more about ...

    1 Hour Later
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    Robyn |Principal

    I might be able to help with the research in this regard. please feel free to contact me...

    1 Hour Later
+23 Other Responses
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Medical Device Fda Approval

Need help with applying for fda approval of medical device. Would like to pursue either a 510k application ( if predicate devise exists) or if not, de novo application

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    Cynthia |Regulatory Affairs Consultant

    Hello, I am an independent *****ultant specializing in class II medical devices. I devel...

    2 Hours Later
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    Andrea |Principal Consultant

    I have written many 510(k)s and some de novo *****ughout my 20 year career as a Regulato...

    2 Hours Later
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    Susan |President and Founder

    I can help you with this project. Please take a look at my background...

    2 Hours Later
+31 Other Responses
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