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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, penile
510(k) Number K912935
Device Name AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Applicant Contact QUINLAN SMITH
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
11001 BREN RD. EAST
MINNETONKA,  MN  55343
Correspondent Contact QUINLAN SMITH
Regulation Number876.3630
Classification Product Code
FAE  
Date Received07/05/1991
Decision Date 03/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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