Details
Part 3: 510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)
Presenter(s):Marjorie Shulman - Consumer Safety Officer - Premarket Notification (510(k)) Staff - Office of Device Evaluation, CDRH, FDA
Date:10/20/2008
Time:1:18 PM CST
Length:12 Minutes 27 Seconds
Description:Premarket Notification 510(k) and 513(g) Request for Information Basic Introduction (Part 3)