The following data is part of a premarket notification filed by Sanarus Medical, Inc. with the FDA for Sanarus V2 Treatment System.
| Device ID | K073533 |
| 510k Number | K073533 |
| Device Name: | SANARUS V2 TREATMENT SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | SANARUS MEDICAL, INC. 4696 WILLOW RD. Pleasanton, CA 94588 |
| Contact | Lisa Henry |
| Correspondent | Lisa Henry 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 | 2007-12-17 |
| Decision Date | 2008-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868390000204 | K073533 | 000 |