Clearance Summary
NEUTRAL POS-CHAIR SURGEON CHAIR received FDA 510(k) clearance under submission number K842030, sponsored by Neutral Pos-Chair Co.. 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 1984-07-23.
- Submission: K842030
- Applicant / Sponsor: Neutral Pos-Chair Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1984-07-23
Classification & Regulation
This clearance is catalogued under FDA product code FZK and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.