Clearance Summary
30 ML OR 60 ML PEDI-SYRINGE FILTER received FDA 510(k) clearance under submission number K050805, sponsored by Blood Products Specialties, LLC. 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 2005-06-20.
- Submission: K050805
- Applicant / Sponsor: Blood Products Specialties, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2005-06-20
Classification & Regulation
This clearance is catalogued under FDA product code BRZ and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.