FDA 510(k) Application Details - K980982

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K980982
Device Name	Plasma, Coagulation Control
Applicant	AVOCET MEDICAL, INC. 1696 DELL AVE. CAMPBELL, CA 95008 US Other 510(k) Applications for this Company
Contact	Judith Blunt 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	03/17/1998
Decision Date	04/16/1998
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