Clearance Summary
CAREO SAFETY SYRINGE FOR U-100 INSULIN received FDA 510(k) clearance under submission number K061055, sponsored by Life-Shield Products, Inc.. 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 2006-07-10.
- Submission: K061055
- Applicant / Sponsor: Life-Shield Products, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2006-07-10
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.