FDA 510(k) Application Details - K991439

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K991439
Device Name	Plasma, Coagulation Control
Applicant	EUROPEAN CONCERTED ACTION ON ANTICOAGULATION OXFORD ROAD MANCHESTER M13 9PT,GB GB Other 510(k) Applications for this Company
Contact	L. POLLER Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/1999
Decision Date	12/20/1999
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