Clearance Summary
HEMOSPAL KITS A1, A2D, AO, & A1D received FDA 510(k) clearance under submission number K901368, sponsored by Gambro-Hospal, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1990-08-02.
- Submission: K901368
- Applicant / Sponsor: Gambro-Hospal, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1990-08-02
Classification & Regulation
This clearance is catalogued under FDA product code FJG and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.