PREMIO
FDA 510(k) clearance K060465 · decided 2007-01-17
Clearance details
- K-number
- K060465
- Device name
- PREMIO
- Applicant
- Peters Surgical
- Decision
- Substantially Equivalent
- Date received
- 2006-02-22
- Decision date
- 2007-01-17
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- MXW
- Device class
- 2
- Regulation number
- 878.5010
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bobigny, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NUVANCE* FACIAL REJUVENATION SYSTEM (K052953) | ETHICON, Inc. | 2006-03-06 |
Recalls involving this device
No recalls on record reference this clearance.