Clearance Summary
COT, FOLDING, HOSPITAL, ALUMINUM received FDA 510(k) clearance under submission number K863691, sponsored by Brenner Metal Prod Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1987-01-20.
- Submission: K863691
- Applicant / Sponsor: Brenner Metal Prod Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5120
- Decision date: 1987-01-20
Classification & Regulation
This clearance is catalogued under FDA product code FNJ and 21 CFR 880.5120, within the General Hospital review panel as a Class I device.