510(k) K071823
K071823 is an FDA 510(k) premarket notification submitted by Surgisil for the device "PERMA FACIAL IMPLANTS". The FDA issued a decision of Substantially Equivalent on September 19, 2007. The device falls under product code ODU (Facial Implant), a Class II device regulated under 21 CFR 878.3500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2007
- Date Received
- July 3, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Facial Implant
- Device Class
- Class II
- Regulation Number
- 878.3500
- Review Panel
- SU
- Submission Type
For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.