The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Gynecare Tvt Exact Continence System.
| Device ID | K132054 |
| 510k Number | K132054 |
| Device Name: | GYNECARE TVT EXACT CONTINENCE SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Contact | Susan Lin |
| Correspondent | Susan Lin ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2013-08-23 |
| Summary: | summary |