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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K012342
Device Name AMS SOFT-TISSUE APPROXIMATION SYSTEM
Applicant
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Applicant Contact ELSA A LINKE
Correspondent
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Correspondent Contact ELSA A LINKE
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
KGS  
Date Received07/24/2001
Decision Date 09/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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