Clearance Summary
OH-HARRIS received FDA 510(k) clearance under submission number K801388, 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 1980-07-28.
- Submission: K801388
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4200
- Decision date: 1980-07-28
Classification & Regulation
This clearance is catalogued under FDA product code KIH and 21 CFR 888.4200, within the Orthopedic review panel as a Class I device.