Clearance Summary
TABLE, OPERATING ROOM, HYDRAULIC received FDA 510(k) clearance under submission number K863161, sponsored by Kamiya Tsusan Kaisha, Ltd.. 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 1986-09-05.
- Submission: K863161
- Applicant / Sponsor: Kamiya Tsusan Kaisha, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1986-09-05
Classification & Regulation
This clearance is catalogued under FDA product code FWW and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.