V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
FDA 510(k) clearance K062896 · decided 2007-01-03
Clearance details
- K-number
- K062896
- Device name
- V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
- Applicant
- Sanarus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-27
- Decision date
- 2007-01-03
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.