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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, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K033636
Device Name AMS LARGE PORE POLYPROPYLENE MESH
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Applicant Contact elsa a linke
Correspondent
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Correspodent Contact elsa a linke
Regulation Number878.3300
Classification Product Code
OTP  
Subsequent Product Code
OTO  
Date Received11/19/2003
Decision Date 12/31/2003
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
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