Clearance Summary
DUOPRO SAFETY SYRINGE (DUOPROSS) received FDA 510(k) clearance under submission number K022806, 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 2002-09-19.
- Submission: K022806
- 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: 2002-09-19
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.