AMS COLLAGEN DERMAL MATRIX— 510(k) K050445

Name: FDA 510(k) clearance K050445
Creator: U.S. Food and Drug Administration
Published: 2005-06-17

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K050445 for AMS COLLAGEN DERMAL MATRIX, Substantially Equivalent on 2005-06-17. Applicant: American Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code PAG
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2005-02-22
Decision date: 2005-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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