FDA 510(k) Application Details - K070453

Device Classification Name	Fibrin Split Products   More FDA Info for this Device
510(K) Number	K070453
Device Name	Fibrin Split Products
Applicant	OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH 3131 WEST ROYAL LANE IRVING, TX 75063-3104 US Other 510(k) Applications for this Company
Contact	STEPHANIE G SCHWARTZ 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	02/16/2007
Decision Date	06/11/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review