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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, polymeric
510(k) Number K090934
Device Name PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Applicant Contact sarah meyer
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Correspodent Contact sarah meyer
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/02/2009
Decision Date 06/02/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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