FDA 510(k) Application Details - K981752

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K981752
Device Name	Plasma, Coagulation Control
Applicant	BIOPOOL INTL., INC. 6025 NICOLLE ST. VENTURA, CA 93003 US Other 510(k) Applications for this Company
Contact	MICHAEL D BICK 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	05/18/1998
Decision Date	06/15/1998
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