FDA 510(k) Application Details - K072727

Device Classification Name	Test, Time, Prothrombin   More FDA Info for this Device
510(K) Number	K072727
Device Name	Test, Time, Prothrombin
Applicant	HEMOSENSE, INC. 651 RIVER OAKS PARKWAY SAN JOSE, CA 95134 US Other 510(k) Applications for this Company
Contact	DOUG RUNDLE Other 510(k) Applications for this Contact
Regulation Number	864.7750   More FDA Info for this Regulation Number
Classification Product Code	GJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2007
Decision Date	10/26/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review