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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
510(k) Number K050445
Device Name AMS COLLAGEN DERMAL MATRIX
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Applicant Contact ELSA LINKE
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA,  MN  55343
Correspondent Contact ELSA LINKE
Regulation Number878.3300
Classification Product Code
PAG  
Subsequent Product Codes
FTM   PAI   PAJ  
Date Received02/22/2005
Decision Date 06/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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