VOLISTA 400; VOLISTA 600
FDA 510(k) clearance K130513 · decided 2013-05-08
Clearance details
- K-number
- K130513
- Device name
- VOLISTA 400; VOLISTA 600
- Applicant
- Maquet S.A.S.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-27
- Decision date
- 2013-05-08
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- FTD
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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