The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Intemesh Silicone-coated Sling And Surgical Mesh With Inhibizone, Model 72403304.
| Device ID | K042592 |
| 510k Number | K042592 |
| Device Name: | INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Kristyn Benson |
| Correspondent | Kristyn Benson AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-09-23 |
| Decision Date | 2004-12-14 |
| Summary: | summary |