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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
  2. Profile Picture

    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

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

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
  2. Profile Picture

    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 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
  2. Profile Picture

    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
  3. Profile Picture

    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
+29 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

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

    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
    2. Profile Picture

      Mark |Clinical Associate Professor, Oregon Hea

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

      4 Minutes Later
    3. Profile Picture

      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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    Fda 510k

    Canadian company personal lubricant class ii medical device prepare 510k submission

    1. Profile Picture

      James |CEO

      To Whom it May Concern, my company is one of the premier leaders in the ***** 510k submissi...

      8 Minutes Later
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      Larry |Served as CEO, VP Sales and Marketing, R

      Dear sir, I am responding to your posting on Zintro for an FDA 510(k) expert consultant. This is ...

      10.2 Hours Later
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      Georganne |Consultant

      Hi, I have been a *****essional for over 35 years, specializing in medical devices. As a c...

      12.5 Hours Later
    +8 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
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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 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.

      +undefined 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
      2. Profile Picture

        Cynthia |Regulatory Affairs Consultant

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

        6.3 Hours Later
      3. Profile Picture

        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

      Need a special 510k written for a class ii device that includes hardware. Will also need new risk analysis, design controls, testing, and procedures written for bench testing. Looking for pricing, even if it is estimated.

      1. Profile Picture

        steve |ceo

        Hi. We've done over 100 special 510k's and all that goes with it. Happy to quote price range, confi...

        38 Minutes Later
      2. Profile Picture

        Les |Principal

        With more than 40 years in the *****stries and a successful track records of submission...

        39 Minutes Later
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        Hrishikesh |Consultant

        We can definitely work on preparing all aspects of a 510(k) submission. The pricing will depend on ...

        45 Minutes Later
      +20 Other Responses
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