The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Novasilk Mesh.
| Device ID | K053414 |
| 510k Number | K053414 |
| Device Name: | MENTOR NOVASILK MESH |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | MENTOR CORP. 201 MENTOR DRIVE Santa Barbara, CA 93111 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford MENTOR CORP. 201 MENTOR DRIVE Santa Barbara, CA 93111 |
| Product Code | OTP |
| Subsequent Product Code | OTO |
| Subsequent Product Code | PAI |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-07 |
| Decision Date | 2005-12-27 |
| Summary: | summary |