FDA 510(k) Application Details - K090003

Device Classification Name	Injector, Fluid, Non-Electrically Powered   More FDA Info for this Device
510(K) Number	K090003
Device Name	Injector, Fluid, Non-Electrically Powered
Applicant	BIOJECT, INC. 20245 S.W. 95TH AVE. TUALATIN, OR 97062 US Other 510(k) Applications for this Company
Contact	KRIS RICHARD Other 510(k) Applications for this Contact
Regulation Number	880.5430   More FDA Info for this Regulation Number
Classification Product Code	KZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2009
Decision Date	04/02/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review