SANARUS V2 TREATMENT SYSTEM
FDA 510(k) clearance K073533 · decided 2008-02-07
Clearance details
- K-number
- K073533
- Device name
- SANARUS V2 TREATMENT SYSTEM
- Applicant
- Sanarus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-17
- Decision date
- 2008-02-07
- Days to decision
- 52 days
- Clearance type
- Special
- 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.