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Recent Fda 510k Inquiries

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Fda 510k

Need an independent fda 510k consultant to prepare a 510k submission. Not looking for consulting groups. Must be a single person seperate from a group.

  1. Profile Picture

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

    Hello, I am an FDA 510(k) consultant with 25 years of experience. I work alone and I do this type o...

    7 Minutes Later
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    Antonio |Director

    I have submitted several successful 510ks and 510k with clinical trials. I alos have access to over ...

    46 Minutes Later
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    James |Owner

    Class II? Class III? Timeframe? Onsite or remote or both? I authored FDA 510(k) K*****. Jim Joy...

    1.1 Hours Later
+29 Other Responses
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Fda 510k For Light Therapy Device

We need to determine whether or not a led light therapy device needs a 510k. We have seen some led light therapy devices have a 510k and some do do not. Looking for someone with expertise in this specific area.

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    Fda 510k

    Looking for a seasoned 510k submission expert with significant proven experience with ivds. - need someone with experience in the gastrointestinal space, medical devices and colonoscopy.

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      Medical Device Labeling And Compliance

      Looking for a subject matter regulatory expert for fda 510k medical device labeling on pouches, secondary packaging, primary packaging and dfu requirements. Need to review labels and content.

        +undefined Other Responses
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        Fda 510k

        I need someone to write a fda 510k for a class ii product.

        1. Profile Picture

          James |CEO

          To Whom it may Concern, I have 15+ years working with Class II medical devices. I have worked with ...

          4.3 Hours Later
        2. Profile Picture

          Andrea |Principal Consultant

          Good Afternoon, I have about 20 years of experience in medical device *****irs, I can wri...

          4.7 Hours Later
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          Paul |CEO and Co-Founder

          Please contact our in-house *****irs expert, Rich Anderson at (916) *****....

          4.8 Hours Later
        +24 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.

        1. Profile Picture

          Michael |Regulatory Project Manager

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

          5 Minutes Later
        2. Profile Picture

          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
        3. Profile Picture

          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

        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.

        1. Profile Picture

          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 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.

        1. Profile Picture

          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

        We are a small medical device company. I have a fda cleared device and i want to add an indication for which no predicate exists. Fda recommended de novo 510(k). I have engaged hogan lovells to manage this submission but i need someone to be our arms, legs, and mind to prepare for pre-sub fda meeting and assist in submission creation. I need a hands-on doer to do real work, not just someone to tell me what to do. This is an exciting new product that is making a difference in lives. It is ce marked and approved in many countries. We are based in gaithersburg maryland just north of washington, dc.

          +undefined Other Responses
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          Fda 510k

          A company that makes personal lubricant class ii medical device is looking for consultants with personal lubricant 510k submission experience

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            John |Owner and Sr. Consultant

            My ***** filed numerous personal lubricant 510(k)s. We would be pleased to do this work on ...

            1.5 Hours Later
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            Anne |Zintro Expert

            I have worked on many 510(k)s for medical devices (class II). I am a medical writer based in Chicago...

            2.2 Hours Later
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            Diane |Zintro Expert

            As a former FDA reviewer and 15+ years of experience in the medical device industry preparing 510Ks ...

            9.1 Hours Later
          +10 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.

          1. Profile Picture

            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
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          Fda 510k Filing

          I need an independent consultant to file substantial equivalence 510 k with fda

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            Polina |Zintro Expert

            I support 510K fillings for drug products. Email me at ***** ...

            1.6 Hours Later
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            Ee Bin |Owner & Consultant

            Hi there, is it a device or drug or *****ce or IVD? cheers, Ee Bin www.access2hc.com...

            2.6 Hours Later
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            Parul |Regulatory Consultant, Elexes Inc.

            I would love to help you on this. I have done a number of 510(k) fillings and successfully gotten FD...

            5.3 Hours Later
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