REGEN COLLAGEN SCAFFOLD (CS)— 510(k) K082079

Name: FDA 510(k) clearance K082079
Creator: U.S. Food and Drug Administration
Published: 2008-12-18

Substantially Equivalent

Regen Biologics, Inc.

FDA 510(k) clearance K082079 for REGEN COLLAGEN SCAFFOLD (CS), Substantially Equivalent on 2008-12-18. Applicant: Regen Biologics, Inc.. Device class: 2.

Clearance details

Applicant: Regen Biologics, Inc.
Product code: Code OLC
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2008-07-23
Decision date: 2008-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

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