PJK — Tissue Adhesive For Internal Use Class III
FDA product code PJK covers "Tissue Adhesive For Internal Use", a Class III medical device regulated under 21 CFR 878.4010. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.
Classification Details
- Product Code
- PJK
- Device Class
- Class III
- Regulation Number
- 878.4010
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.