The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Obtape Trans-obturator Tape.
| Device ID | K031767 |
| 510k Number | K031767 |
| Device Name: | MENTOR OBTAPE TRANS-OBTURATOR TAPE |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Contact | Donna Crawford |
| Correspondent | Donna Crawford MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-09 |
| Decision Date | 2003-07-17 |
| Summary: | summary |