FDA 510(k) Application Details - K993276

Device Classification Name	Fibrin Split Products   More FDA Info for this Device
510(K) Number	K993276
Device Name	Fibrin Split Products
Applicant	AGEN BIOMEDICAL LTD. 7 & 11 DURBELL ST., ACACIA RIDGE BRISBANE, QUEENSLAND 4110 AU Other 510(k) Applications for this Company
Contact	RUSSEL RICHARDS 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	09/30/1999
Decision Date	12/14/1999
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