Clearance Summary
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS received FDA 510(k) clearance under submission number K904223, sponsored by Baxter Healthcare 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 1990-10-26.
- Submission: K904223
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1990-10-26
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.