Clearance Summary
DELTA-LITE CASTING RESIN received FDA 510(k) clearance under submission number K854341, 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 1985-11-22.
- Submission: K854341
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5940
- Decision date: 1985-11-22
Classification & Regulation
This clearance is catalogued under FDA product code LGF and 21 CFR 888.5940, within the Orthopedic review panel as a Class I device.