Clearance Summary
BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE received FDA 510(k) clearance under submission number K982558, sponsored by Bd/Preefil. 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 2000-03-08.
- Submission: K982558
- Applicant / Sponsor: Bd/Preefil
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2000-03-08
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.