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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.

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    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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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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510k Clearance

We are a microcurrent therapy product development company. We are 90% completed with our fda 510(k) prescription only submission for a class ii tens device. Our regulatory consultant has had to take a leave of absence. We need a regulatory affairs consultant to help us complete the submission asap.

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    Ram |CEO-Founder

    We can assist with this. Ram Balani...

    1 Minute Later
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    Alan |President and Senior Consultant

    We have the experience needed, and will commit to *****ort. Looking forward to our success...

    1 Minute Later
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    Daniel |Clinical Scientist, Regulatory Affairs C

    I can help you complete your 510K ASAP. Have extensive experience and 100% success ***** back to...

    1 Minute Later
+20 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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Fda 510k

I need a consultant to assist my client with litigation involving the use of 510k. The case is in florida, and i am in ny.

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    Michael |Regulatory Project Manager

    President of *****irs Associates, Stephen Goldner, has 40 years experience in regulatory a...

    5 Minutes Later
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    Charles |VP, Sr Director, National sales Mgr, VP

    Yes we can help. We do assist clients in the 510k are in all facets. If you want to further discuss ...

    14 Minutes Later
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    Timothy |Principal

    I am former FDA and as a consultant for 18 + years I have furnished clients with quality system audi...

    15 Minutes Later
+19 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 510k

A pma submission expert for a submission of a new cosmetic filler similar to radiesse that could possibly be combined with a lidocaine for pain management and would be delivered with thawed cryo-preserved amniotic allograft component that is mixed once in a liquid format state. The expert must be willing to testify in court.

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    Michael |Regulatory Project Manager

    *****irs Associates (RAA) can assist with your device submission. RAA has completed over ...

    1 Minute Later
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    Plamena |Principal Consultant

    Preferred *****ulting has PMA experience including for *****ucts and loads of C...

    1 Minute Later
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    DANIEL |CEO

    Hello. We are a group of medical device consultants including expertise in quality Management and FD...

    1 Minute Later
+8 Other Responses
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Fda Medical Device

I need help filing a special 510k for my product. Thank you

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    Larry |Served as CEO, VP Sales and Marketing, R

    Hello, I am an FDA *****irs Consultant. I prepare Special FDA 510(k) submissions for Medi...

    7 Minutes Later
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    Les |Principal

    I can help you with this as I've successfully submitted numerous 510(K)s. Please contact me at fdaq...

    10 Minutes Later
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    NO WAY TO |Chief Experience Officer

    We can help with the usability aspects iso ***** for your 510k by conducting and reporting on your s...

    16 Minutes Later
+13 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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Fda 510k

Hello, i'm looking for a consultant to assist with an fda 510k submission for a: class ii ophthalmic medical device if you have expertise in this area, please let me know. Thank you.

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    Les |Principal

    I have more than 40 years in the *****stries and have successfully submitted numerous 5...

    1 Minute Later
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    Mark |Clinical Associate Professor, Oregon Hea

    I have helped many companies achieve 510k clearance for ophthalmic devices, from imaging systems to ...

    4 Minutes Later
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    LAWRENCE |President and Ph D

    Please see my profile. I have worked as VP for a major company for contact lenses. I have been consu...

    6 Minutes Later
+24 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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Medical Devices

I have a medical device which i would like to bring to the us market. We would need an expert that can register our product with the fda, it may need a 510k or pma etc.

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    Susan M |http://www.bowleyconsulting.org

    I would be willing to waive the fee for this 1 hr consult call, if you retain my firm for additional...

    12 Minutes Later
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    John |President

    Having worked with 510(k)s for years, I would like to discuss your product needs with you. Thanks, J...

    25 Minutes Later
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    Michael |President

    Hello Sharonw, Thank you for the inquiry. We have the expertise to help you with your approval via...

    1.3 Hours Later
+20 Other Responses
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