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FMMC Briefing: "The Essentials of a 510(k) Medical Device Submission"
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FMMC Briefing:

Bi-monthly FMMC networking and educational event.

When: October 11, 2017
8:00 AM
Where: Hilton Carillon Park
950 Lake Carillon Drive
Van Gogh Room
St. Petersburg, Florida  33716
United States
Contact: FMMC
(850) 270-3158

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The ESSENTIALS of a 510(k) Medical Device Submission


The 510(k) clearance process is arguably the most important and long-standing medical device approval pathway in our regulatory scheme. Please join us for this special FMMC session covering the key elements of the 510(k) process and submission, including a focus on the most critical pieces of information that trigger questions by reviewers and recent changes to the 510(k) program.


Our Speaker:

Paul Dryden, President

Promedic, LLC


Paul Dryden serves as President of ProMedic, Inc., a medical device regulatory and business development consulting firm. Mr. Dryden has been in the medical device industry since 1975 and has lead hundreds of successful 510(k) submissions. Prior to forming Promedic, Inc. in 1992, Mr. Dryden was President of Dryden Corporation, Indianapolis, IN, an anesthesia / respiratory disposable manufacturer.



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