Clearance Summary
ORTHO-J, INC. BEK-JS-004 received FDA 510(k) clearance under submission number K891917, sponsored by Ortho-J, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1989-05-26.
- Submission: K891917
- Applicant / Sponsor: Ortho-J, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1989-05-26
Classification & Regulation
This clearance is catalogued under FDA product code JEB and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.