The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Triangle Silicone-coated Sling And Surgical Mesh.
Device ID | K002721 |
510k Number | K002721 |
Device Name: | AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH |
Classification | Mesh, Surgical, Polymeric |
Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
Contact | Ginger Z Glaser |
Correspondent | Ginger Z Glaser AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-31 |
Decision Date | 2000-11-29 |
Summary: | summary |