Clearance Summary
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe received FDA 510(k) clearance under submission number K142620, sponsored by Excelsior Medical Corporation. 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 2014-12-12.
- Submission: K142620
- Applicant / Sponsor: Excelsior Medical Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2014-12-12
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.