FDA 510(k) Application Details - K994384

Device Classification Name	Injector, Fluid, Non-Electrically Powered   More FDA Info for this Device
510(K) Number	K994384
Device Name	Injector, Fluid, Non-Electrically Powered
Applicant	BIOJECT, INC. 7620 S.W. BRIDGEPORT RD. PORTLAND, OR 97224 US Other 510(k) Applications for this Company
Contact	NANCY GERTLAR 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	12/28/1999
Decision Date	06/22/2000
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