FDA 510(k) Application Details - K081532

Device Classification Name	Injector, Fluid, Non-Electrically Powered   More FDA Info for this Device
510(K) Number	K081532
Device Name	Injector, Fluid, Non-Electrically Powered
Applicant	PHARMAJET, INC. 221 CORPORATE CIRCLE SUITE D GOLDEN, CO 80401 US Other 510(k) Applications for this Company
Contact	RON BAUER 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	06/02/2008
Decision Date	02/26/2009
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