Clearance Summary
10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE received FDA 510(k) clearance under submission number K034031, sponsored by M.K. Meditech Co. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2004-01-21.
- Submission: K034031
- Applicant / Sponsor: M.K. Meditech Co. , Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2004-01-21
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.