DESARA MINI
FDA 510(k) clearance K103418 · decided 2011-11-30
Clearance details
- K-number
- K103418
- Device name
- DESARA MINI
- Applicant
- Caldera Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-22
- Decision date
- 2011-11-30
- Days to decision
- 373 days
- Clearance type
- Traditional
- Product code
- PAH
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Agoura Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.