AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH


Device Classification Name

mesh, surgical, polymeric

510(k) Number K002721
Device Name AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
Original Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren rd., west
minnetonka, 
MN 
55343

Original Contact ginger z glaser
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 08/31/2000
Decision Date 11/29/2000
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