PFC — Cultured Human Cell Skin Dressing Class III
FDA product code PFC covers "Cultured Human Cell Skin Dressing", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- PFC
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.