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510(k) K821627

THE ARTIFICIAL URINARY SPHINCTER by American Medical Systems, Inc. — Product Code FAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1982
Date Received
June 2, 1982
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

  • K912934 — AMS SPHINCTER 800 URINARY PROSTHESIS (March 18, 1992)