Clearance Summary
ARMBOARD AND THE BOARD received FDA 510(k) clearance under submission number K833664, sponsored by Rick Robbin & Frederick Auerbach. 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 1983-12-27.
- Submission: K833664
- Applicant / Sponsor: Rick Robbin & Frederick Auerbach
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.3910
- Decision date: 1983-12-27
Classification & Regulation
This clearance is catalogued under FDA product code BTX and 21 CFR 878.3910, within the General, Plastic Surgery review panel as a Class I device.