THE ARTIFICIAL URINARY SPHINCTER— 510(k) K821627

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..

Clearance details

Applicant
American Medical Systems, Inc.
Product code
Code FAG
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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