The following data is part of a premarket notification filed by Sanarus Medical, Inc. with the FDA for V2 Treatment System (v2 Console, V2 Ice Probe, V2 Dewars) Models; Vs3000, Vp0600, Vd0600.
| Device ID | K062896 |
| 510k Number | K062896 |
| Device Name: | V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | SANARUS MEDICAL, INC. 4696 WILLOW RD. Pleasanton, CA 94588 |
| Contact | Alan Marquardt |
| Correspondent | Alan Marquardt SANARUS MEDICAL, INC. 4696 WILLOW RD. Pleasanton, CA 94588 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-27 |
| Decision Date | 2007-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868390000228 | K062896 | 000 |
| 00868390000211 | K062896 | 000 |