Clearance Summary
MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS received FDA 510(k) clearance under submission number K896976, sponsored by Asahi Medical Co., Ltd.. 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 1990-01-24.
- Submission: K896976
- Applicant / Sponsor: Asahi Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1990-01-24
Classification & Regulation
This clearance is catalogued under FDA product code CAK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.