The following data is part of a premarket notification filed by Gynecare Center with the FDA for Gynecare Tension-free Vaginal Tape System.
| Device ID | K012628 |
| 510k Number | K012628 |
| Device Name: | GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | GYNECARE CENTER P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Gregory Jones |
| Correspondent | Gregory Jones GYNECARE CENTER P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-10-26 |
| Summary: | summary |