Clearance Summary
DELTA-TECH(TM) CAST REMOVAL SYSTEM received FDA 510(k) clearance under submission number K895861, 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 1989-10-19.
- Submission: K895861
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5960
- Decision date: 1989-10-19
Classification & Regulation
This clearance is catalogued under FDA product code LGH and 21 CFR 888.5960, within the Orthopedic review panel as a Class I device.