The following data is part of a premarket notification filed by Mentor Urology, Inc. with the FDA for Mentor Urology Triple Rib Occlusion Wrap For Male Incontinence.
| Device ID | K970308 |
| 510k Number | K970308 |
| Device Name: | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE |
| Classification | Clamp, Penile |
| Applicant | MENTOR UROLOGY, INC. 1615 WEST RIVER RD., NORTH Minneapolis, MN 55411 |
| Contact | Donald E Blisard |
| Correspondent | Donald E Blisard MENTOR UROLOGY, INC. 1615 WEST RIVER RD., NORTH Minneapolis, MN 55411 |
| Product Code | FHA |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-27 |
| Decision Date | 1997-04-02 |
| Summary: | summary |