Clearance Summary
QUIKCLOT NOSEBLEED received FDA 510(k) clearance under submission number K080247, sponsored by Z-Medica Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2008-02-27.
- Submission: K080247
- Applicant / Sponsor: Z-Medica Corporation
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4780
- Decision date: 2008-02-27
Classification & Regulation
This clearance is catalogued under FDA product code LYA and 21 CFR 874.4780, within the Ear, Nose, Throat review panel as a Class I device.