Clearance Summary
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER received FDA 510(k) clearance under submission number K070010, sponsored by Z-Medica Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2007-01-25.
- Submission: K070010
- Applicant / Sponsor: Z-Medica Corporation
- Clearance pathway: Special
- Review panel: Unknown
- Device class:
- Decision date: 2007-01-25
Classification & Regulation
This clearance is catalogued under FDA product code QSY , within the Unknown review panel as a device.