FDA 510(k) Application Details - K072288

Device Classification Name	Fibrin Split Products   More FDA Info for this Device
510(K) Number	K072288
Device Name	Fibrin Split Products
Applicant	MITSUBISHI KAGAKU IATRON 701 FIFTH AVENUE FLOOR 42 SEATTLE, WA 98104 US Other 510(k) Applications for this Company
Contact	HELEN LANDICHO Other 510(k) Applications for this Contact
Regulation Number	864.7320   More FDA Info for this Regulation Number
Classification Product Code	GHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2007
Decision Date	05/06/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review