PERMA FACIAL IMPLANTS
FDA 510(k) clearance K071823 · decided 2007-09-19
Clearance details
- K-number
- K071823
- Device name
- PERMA FACIAL IMPLANTS
- Applicant
- Surgisil
- Decision
- Substantially Equivalent
- Date received
- 2007-07-03
- Decision date
- 2007-09-19
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- ODU
- Device class
- 2
- Regulation number
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.