Clearance Summary
CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) received FDA 510(k) clearance under submission number K052397, sponsored by Life-Shield Products, Inc.. 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 2005-12-22.
- Submission: K052397
- Applicant / Sponsor: Life-Shield Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2005-12-22
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.