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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Urethral Sphincter
510(k) Number K912934
Device Name AMS SPHINCTER 800 URINARY PROSTHESIS
Applicant
American Medical Systems, Inc.
11001 Bren Rd. E.
Minnetonka,  MN  55343
Applicant Contact QUINLAN SMITH
Correspondent
American Medical Systems, Inc.
11001 Bren Rd. E.
Minnetonka,  MN  55343
Correspondent Contact QUINLAN SMITH
Classification Product Code
FAG  
Date Received07/05/1991
Decision Date 03/18/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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