Clearance Summary
CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML received FDA 510(k) clearance under submission number K072037, sponsored by Life-Shield Products, Inc.. 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 2007-08-08.
- Submission: K072037
- Applicant / Sponsor: Life-Shield Products, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2007-08-08
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.