HYDRASOLVE LIPOPLASTY SYSTEM
FDA 510(k) clearance K130152 · decided 2013-04-18
Clearance details
- K-number
- K130152
- Device name
- HYDRASOLVE LIPOPLASTY SYSTEM
- Applicant
- Andrew Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-01-22
- Decision date
- 2013-04-18
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- MUU
- Device class
- 2
- Regulation number
- 878.5040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Haddonfield, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.