Clearance Summary
.9% NORMAL SALINE TUBE/STERILE WATER TUBE received FDA 510(k) clearance under submission number K926405, sponsored by Gam-Med Packaging Corp.. 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 1994-02-03.
- Submission: K926405
- Applicant / Sponsor: Gam-Med Packaging Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1994-02-03
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.