Clearance Summary
WUZHOU SYRINGE, WITH/WITHOUT NEEDLE received FDA 510(k) clearance under submission number K060211, sponsored by Wenzhou Wuzhou Group 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 2006-02-10.
- Submission: K060211
- Applicant / Sponsor: Wenzhou Wuzhou Group Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2006-02-10
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.