Clearance Summary
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES received FDA 510(k) clearance under submission number K031748, sponsored by Vitalcare Group, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-08-27.
- Submission: K031748
- Applicant / Sponsor: Vitalcare Group, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2003-08-27
Classification & Regulation
This clearance is catalogued under FDA product code EZL and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.