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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 K002721
Device Name AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka,  MN  55343
Contact ginger z glaser
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/31/2000
Decision Date 11/29/2000
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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