Clearance Summary
ROWE SHOULDER INSTR. FOR BANKHART REPAIR received FDA 510(k) clearance under submission number K820344, sponsored by New England Surgical Instrument Corp.. 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 1982-03-08.
- Submission: K820344
- Applicant / Sponsor: New England Surgical Instrument Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1982-03-08
Classification & Regulation
This clearance is catalogued under FDA product code HTD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.