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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 K951716
Device Name AMS 650 MALLERABLE PENIEL PROSTHESIS
Applicant
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Applicant Contact DENNIS TOUSSAINT
Correspondent
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Correspondent Contact DENNIS TOUSSAINT
Regulation Number876.3630
Classification Product Code
FAE  
Date Received04/14/1995
Decision Date 07/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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