THE ARTIFICIAL URINARY SPHINCTER— 510(k) K821627

Name: FDA 510(k) clearance K821627
Creator: U.S. Food and Drug Administration
Published: 1982-08-10

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K821627 for THE ARTIFICIAL URINARY SPHINCTER, Substantially Equivalent on 1982-08-10. Applicant: American Medical Systems, Inc.. Device class: 3.

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code FAG
Device class: Class 3
Advisory panel: Unknown
Date received: 1982-06-02
Decision date: 1982-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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