Clearance Summary
HEMATASTAT C-70B received FDA 510(k) clearance under submission number K913128, sponsored by Separation Technology, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1991-09-23.
- Submission: K913128
- Applicant / Sponsor: Separation Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6400
- Decision date: 1991-09-23
Classification & Regulation
This clearance is catalogued under FDA product code GKG and 21 CFR 864.6400, within the Hematology review panel as a Class II device.