Clearance Summary
P.F.C. APICAL PLUG received FDA 510(k) clearance under submission number K944769, sponsored by Johnson & Johnson Professionals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1994-12-08.
- Submission: K944769
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3320
- Decision date: 1994-12-08
Classification & Regulation
This clearance is catalogued under FDA product code JDL and 21 CFR 888.3320, within the Orthopedic review panel as a Class III device.