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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 stress urinary incontinence, retropubic or transobturator
510(k) Number K011251
Device Name SPARC SLING SYSTEM
Original Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Original Contact ginger s glaser
Regulation Number878.3300
Classification Product Code
OTN  
Date Received04/24/2001
Decision Date 08/01/2001
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
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