MODIFICATION TO ZENIEVA— 510(k) K083721

Substantially Equivalent

River'S Edge Pharmaceuticals, LLC

FDA 510(k) clearance K083721 for MODIFICATION TO ZENIEVA, Substantially Equivalent on 2009-01-08. Applicant: River'S Edge Pharmaceuticals, LLC.

Clearance details

Applicant: River'S Edge Pharmaceuticals, LLC
Product code: Code NAE
Advisory panel: General, Plastic Surgery
Date received: 2008-12-15
Decision date: 2009-01-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

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