FDA 510(k) Application Details - K001461

Device Classification Name	Container, I.V.   More FDA Info for this Device
510(K) Number	K001461
Device Name	Container, I.V.
Applicant	BIOMETRIX LTD. 4 KIRYAT MADA P.O. BOX 45057 JERUSALEM 91450 IL Other 510(k) Applications for this Company
Contact	MIRIAM ABUTBUL Other 510(k) Applications for this Contact
Regulation Number	880.5025   More FDA Info for this Regulation Number
Classification Product Code	KPE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2000
Decision Date	09/11/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review