MODIFICATION TO ZENIEVA— 510(k) K083721

Name: FDA 510(k) clearance K083721
Creator: U.S. Food and Drug Administration
Published: 2009-01-08

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. Device class: 1.

Clearance details

Applicant: River'S Edge Pharmaceuticals, LLC
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
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

Download summary PDF View on FDA.gov ↗

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