AMS SPHINCTER 800 URINARY PROSTHESIS— 510(k) K912934

Name: FDA 510(k) clearance K912934
Creator: U.S. Food and Drug Administration
Published: 1992-03-18

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K912934 for AMS SPHINCTER 800 URINARY PROSTHESIS, Substantially Equivalent on 1992-03-18. 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: 1991-07-05
Decision date: 1992-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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