: This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). 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
17 November 2011, Wilmington, United States
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online training webinars
online training webinars, 1000 N West Street, DE, Suite 1200, Wilmington, 19801, United States
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