Clearance Summary
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION received FDA 510(k) clearance under submission number K912979, sponsored by Labeltape Meditect, 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 1991-10-04.
- Submission: K912979
- Applicant / Sponsor: Labeltape Meditect, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 1991-10-04
Classification & Regulation
This clearance is catalogued under FDA product code KHE and 21 CFR 864.6550, within the Hematology review panel as a Class II device.