Clearance Summary
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE received FDA 510(k) clearance under submission number K001616, sponsored by Abbott Laboratories. 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 2000-07-27.
- Submission: K001616
- Applicant / Sponsor: Abbott Laboratories
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2000-07-27
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.