The following data is part of a premarket notification filed by Sanarus Medical, Inc. with the FDA for Sanarus Visica Treatment System.
| Device ID | K061510 |
| 510k Number | K061510 |
| Device Name: | SANARUS VISICA TREATMENT SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | SANARUS MEDICAL, INC. 4696 WILLOW RD. Pleasanton, CA 94588 |
| Contact | Trena Depel |
| Correspondent | Trena Depel SANARUS MEDICAL, INC. 4696 WILLOW RD. Pleasanton, CA 94588 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-01 |
| Decision Date | 2006-07-18 |
| Summary: | summary |