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510(k) K912934

AMS SPHINCTER 800 URINARY PROSTHESIS by American Medical Systems, Inc. — Product Code FAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1992
Date Received
July 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Urethral Sphincter
Device Class
Class III
Regulation Number
Review Panel
GU
Submission Type

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Other clearances for product code FAG

  • K821627 — THE ARTIFICIAL URINARY SPHINCTER (August 10, 1982)