The following data is part of a premarket notification filed by Mentor Corporation with the FDA for Mentor Aris Suprapubic Surgical Kit.
| Device ID | K053296 |
| 510k Number | K053296 |
| Device Name: | MENTOR ARIS SUPRAPUBIC SURGICAL KIT |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | MENTOR CORPORATION 201 MENTOR DRIVE Santa Barbara, CA 93111 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford MENTOR CORPORATION 201 MENTOR DRIVE 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 | 2005-11-25 |
| Decision Date | 2005-12-15 |
| Summary: | summary |