Clearance Summary
DEVICE FOR REPOSITIONING A BET PATIENT received FDA 510(k) clearance under submission number K813356, sponsored by Ali-Oop Co., 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 1982-02-10.
- Submission: K813356
- Applicant / Sponsor: Ali-Oop Co., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5120
- Decision date: 1982-02-10
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.