AMS FASCIAL-ANCHORING SYSTEM— 510(k) K010277

Name: FDA 510(k) clearance K010277
Creator: U.S. Food and Drug Administration
Published: 2001-03-26

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K010277 for AMS FASCIAL-ANCHORING SYSTEM, Substantially Equivalent on 2001-03-26. Applicant: American Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code NEH
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2001-01-30
Decision date: 2001-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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