Clearance Summary
CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE received FDA 510(k) clearance under submission number K062780, sponsored by Medical Device Manufacturer (Thailand) , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-01-05.
- Submission: K062780
- Applicant / Sponsor: Medical Device Manufacturer (Thailand) , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2007-01-05
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.