Clearance Summary
SALINE IV FLUSH SYRINGE received FDA 510(k) clearance under submission number K002142, sponsored by Emt-Rx. 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 2002-01-28.
- Submission: K002142
- Applicant / Sponsor: Emt-Rx
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2002-01-28
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.