Clearance Summary
EWNL SAFETY SYRINGE WITH NEEDLE received FDA 510(k) clearance under submission number K132557, sponsored by Jiamei-Un Co., 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 2014-06-03.
- Submission: K132557
- Applicant / Sponsor: Jiamei-Un Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2014-06-03
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.