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TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE

K080648 Traditional
Decision Date
2008-05-07
Sponsor / Applicant
Ore-Medix, LLC

Technical Specification

510(k) Submission ID K080648
Product Code QSY
Medical Specialty / Panel Unknown
Decision Date 2008-05-07
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE received FDA 510(k) clearance under submission number K080648, sponsored by Ore-Medix, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2008-05-07.

Classification & Regulation

This clearance is catalogued under FDA product code QSY , within the Unknown review panel as a device.