Clearance Summary
U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER received FDA 510(k) clearance under submission number K922816, sponsored by Up Custom Design, Inc.. 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 1993-07-13.
- Submission: K922816
- Applicant / Sponsor: Up Custom Design, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6900
- Decision date: 1993-07-13
Classification & Regulation
This clearance is catalogued under FDA product code FPP and 21 CFR 880.6900, within the General Hospital review panel as a Class I device.