510(k) K050769

QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172 by Z-Medica Corporation — Product Code QSY

K050769 is an FDA 510(k) premarket notification submitted by Z-Medica Corporation for the device "QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172". The FDA issued a decision of Substantially Equivalent on April 14, 2005. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Z-Medica Corporation has at least 7 other 510(k) clearances on record.