Clearance Summary
O.R. ARMBOARD COVER received FDA 510(k) clearance under submission number K813030, sponsored by Tecnol New Jersey Wound Care, 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 1982-01-18.
- Submission: K813030
- Applicant / Sponsor: Tecnol New Jersey Wound Care, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1982-01-18
Classification & Regulation
This clearance is catalogued under FDA product code FWZ and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.