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Recent 510 K Inquiries

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Medical Device 510 (k)

If your are manufacturing hematology controls and file a 510(k) and decide to move to another location. Do you have to re-file a new 510(k) for the new location.

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    Al |Founder and Consultant

    No, you do not need to file a new 510(k). The 510(k) is a marketing clearance and does not involve ...

    13.6 Hours Later
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    George |Prinicipal Quality Consultant

    No, 510k not required, but compliance to QSR / 21CFR820 is required and in ***** a process r...

    2.1 Days Later
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    Russell |President/Owner

    No a 510(k) will not be required. I would recommend ***** ***** all your ma...

    42.8 Days Later
+6 Other Responses
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Fda 510(k) Guidance

We are developing a simple device that connects a pill container to a smartphone to monitor pharmaceutical adherence. We need guidance on the 510(k) process for development of both our physical product and our software before we go to manufacturing.

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    John |Owner and Sr. Consultant

    ***** discovering another ***** of mobile technology that helps people manage ...

    4.7 Hours Later
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    steve |ceo

    Great idea. We've gotten about 30 computer / wireless software apps reviewed and cleared, plus many ...

    5 Hours 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...

    5.2 Hours Later
+22 Other Responses
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510(k)

**** provides secure digital signature technology that is fda compliant. We are looking for partner(s) to participate in fda's 510(k) e-submission pilot.

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    Cynthia |Regulatory Affairs Consultant

    Hello, I am an independent *****ultant that assists small and start-up medical device manu...

    16 Minutes Later
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    Courtland |CEO

    We are very familiar with ESG and FURLS and look forward to helping you verify the transmission. ...

    3.9 Hours Later
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    New |

    Can we talk early next week. Pem Guerry, *****, *****...

    1 Day Later
+12 Other Responses
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Fda 510(k) Guidance

I would like to get a better understandign of the fda 510(k) process. What is all required in the context of my device. My device is a camera that captures 3d data to allow for highly accurate 3d surface measurements. It will enable better tracking of the healing progress for multiple applications one in particular is chronic wounds. Thank you.

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    Denise |Independent Consultant

    I have 17 years experience with FDA 21 CFR 820 and the most current requirements of the 510(k) proce...

    6.1 Hours Later
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    Nicholas |Principal Consultant

    I have substantial knowledge of the wound healing market as well as experience with the FDA 510K pro...

    8.6 Hours Later
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    Susan |President and Founder

    I would be glad to discuss this project with you. I have given a ***** the new guidance d...

    15.2 Hours Later
+11 Other Responses
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510 K Submission

I am looking for an fda consultant in the massachusetts area, experienced with 510k submissions

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    James |CEO

    To Whom it May concern, I am an expert consultant who has sucessfully submitted and had cleared over...

    2.7 Hours Later
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    Roy |President & CEO

    Depending on your specific requirements, we can likely help. Our practice is focused on go-to-marke...

    3.2 Hours Later
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    Karl |President

    We are ***** Dover, NH just north over the border from Massachusetts and we develop medical dev...

    3.5 Hours Later
+17 Other Responses
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510(k) Premarket Notification

I am looking for someone that can help me perform a temperature over time test. I am working on a wart removal product and it requires that the applicators drop in temperature to an effective temperature rate of -50c with the chemical blend in a canister (liquid gas blend acting as a cryogen). A written report has to be prepared showing the protocols and the results of the test. Hopefully with some photographs of the devices tested. It will be two devices. This is being prepared for submission to the fda for a 510(k) premarket notification. Let me know if this is something you are familiar with.

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    Thomas |Doctor, Radiologist, Neuroradiologist

    We might be able to help you. I am a part owner in a medical consulting group that is focused on me...

    41 Minutes Later
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    Karl |President

    We have a full medical device testing lab and can help with your project. Do you want to set up a ...

    1 Hour Later
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    Gary |VP, R&D

    I am an independent consultant with the resources and experience to design and set up the test appar...

    18 Days Later
+3 Other Responses
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510(k) Clearance

Interested in filing a 510(k) clearance or class 1 filing for radio frequency and aesthetic system, we already have catalog. Interested in flat rate, need proposal, we just became premium member, would like a 15-30 minute conversation prior to contrating.

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    Cynthia |Regulatory Affairs Consultant

    Hello, I am an independent *****ultant specializing in class I and class II medical devic...

    4.8 Hours Later
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    Jorge |

    Dear Cindy, would like to discuss with the you how feasible such can be prior to retaining you. were...

    7.5 Hours Later
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    Daniel |Clinical Scientist, Regulatory Affairs C

    Dear Mr/Mrs, I am confident I can help you in you project to get this device to the market in the s...

    13.2 Hours Later
+13 Other Responses
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Fda 510 K

I am looking for a consultant with 510(k) experience to perform a review of a 510(k) that has been generated.

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    Christopher |Principal Consultant

    Hi, I can assist you with your *****irs needs. Please send me an email and we can provide...

    1 Minute Later
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    Susan |Consultant (former CMO)

    Hello, I have 510K experience as a partner in a healthcare IT company; are you looking for an editor...

    1 Minute Later
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    Eric |Regulatory Associate

    I can certainly perform a review of your 510k....

    1 Minute Later
+22 Other Responses
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Medical Device 510 (k) Submission

Hi we have a medical device, and we are working on our 510k submission. For the fda we need some performance testing/verification testing. Please let me know if you have experience in working with x ray dental sensors and we would love to work with you. Thanks,

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    James |CEO

    To Whom it may concern: Are you specifically looking for someone to do the performance testing/verif...

    4 Hours Later
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    steve |ceo

    HI, Let me know if you need ***** putting the 510k together, we've done a lot of successfu...

    4.1 Hours Later
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    Monther |Sr. Manager

    Hi. I have worked in the dental industry for 7 years and other electro mechanical devices for over 1...

    6.8 Hours Later
+14 Other Responses
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510(k) Standards

We are looking at filing requirements for an allergy skin testing device and if filing a 510(k) is necessary, we seek assistance with preparing and submitting the filing. A predicate device exists under 510(k) filing under **** and a similar device can be seen at ****we look forward to your response.

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    Monther |Sr. Manager

    Hi, I'll be glad to assist you with the assessment to determine if your device require a 510(k) or n...

    56 Minutes Later
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    Andrea |Principal Consultant

    Good Morning, I have 20 years of experience in medical devices, and have filed many 510(k)s. I can...

    1 Hour 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...

    1.3 Hours Later
+19 Other Responses
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510(k)

Dear sir, i represent *************medical engineering pvt. Ltd., mumbai india.George philips was established in 1995 and today, is one of india's leading manufacturer and supplier of 'life saving medical devices and disposables' to the healthcare industry, both domestically and internationally. I am writing to express my interest in seeking your assistance for the submission of 2 of our products (iv flow regulator and disposable pressure transducer kit) for 510 k approval.Kindly provide a quote for processing our application. Awaiting your reply at the earliest.

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    Avner |Quality & Regulation Advisure

    Hello, I'm highly experienced with 510K submissions consulting I will be happy to support you with ...

    1.2 Hours Later
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    Joseph |President

    Dear Sir, I would be happy to ***** the ***** submission of your 510(k)'s to the ...

    1.6 Hours Later
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    Yong |Principal Consultant

    Hello, I worked on IV infusion pumps and assessed IV flow *****gns at Siemens Infusion and...

    3.3 Hours Later
+20 Other Responses
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510(k) Submission

In search of independent senior level consultant possessing extensive 510(k) medical device submission review experience. Prior fda division review experience is highly desirable. This is project work that can all be performed remotely.

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    Brett |CEO

    Hello, I operate a small health consulting group and have an expert in FDA work. He has over 25 ye...

    17 Minutes Later
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    Andrea |Principal Consultant

    Please contact me to discuss. I have solid 510(k) experience, with 510(k) gap analysis and remediat...

    1.4 Hours Later
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    Georganne |Consultant

    What types of products are involved?...

    1.5 Hours Later
+28 Other Responses
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