TANDA MAX
FDA 510(k) clearance K103415 · decided 2011-01-03
Clearance details
- K-number
- K103415
- Device name
- TANDA MAX
- Applicant
- Pharos Life Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-11-22
- Decision date
- 2011-01-03
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- ONE
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cambridge, CA
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.