Clearance Summary
SAFE MATE I.V. FLUID DELIVERY SETS received FDA 510(k) clearance under submission number K962802, sponsored by Biological & Environmental Control Laboratories. 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 1996-08-28.
- Submission: K962802
- Applicant / Sponsor: Biological & Environmental Control Laboratories
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1996-08-28
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.