Clearance Summary
U&U Sterilization Pouch and Roll received FDA 510(k) clearance under submission number K143637, sponsored by U&U Medical Technology Co, Ltd.. 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 2015-09-09.
- Submission: K143637
- Applicant / Sponsor: U&U Medical Technology Co, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2015-09-09
Classification & Regulation
This clearance is catalogued under FDA product code FRG and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.