Clearance Summary
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE received FDA 510(k) clearance under submission number K050131, sponsored by M.K. Meditech 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 2005-04-05.
- Submission: K050131
- Applicant / Sponsor: M.K. Meditech Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2005-04-05
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.