Overview: A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.
Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel
26 June 2012, Wilmington,DE, United States
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Online Training, 1000 N West Street, Suite 1200, Wilmington,DE, 19801, United States
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