Clearance Summary
RUBIN BONE PLANER W/REPLACEABLE BLADE received FDA 510(k) clearance under submission number K884473, sponsored by Neo Contemporary 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 1988-12-09.
- Submission: K884473
- Applicant / Sponsor: Neo Contemporary Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1988-12-09
Classification & Regulation
This clearance is catalogued under FDA product code GAC and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.