FDA 510(k) Application Details - K041564

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K041564
Device Name	Set, I.V. Fluid Transfer
Applicant	BIOJECT MEDICAL TECHNOLOGIES INC. 211 SOMERVILLE ROAD BEDMINSTER, NJ 07921 US Other 510(k) Applications for this Company
Contact	LAURENCE A POTTER Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2004
Decision Date	07/16/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review