Clearance Summary
STERILE FIELD SALINE PRE-FILLED SYRINGE(S) received FDA 510(k) clearance under submission number K082837, sponsored by Excelsior Medical Corp.. 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 2008-12-18.
- Submission: K082837
- Applicant / Sponsor: Excelsior Medical Corp.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2008-12-18
Classification & Regulation
This clearance is catalogued under FDA product code NGT and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.