FDA 510(k) Application Details - K082138

Device Classification Name	Injector, Fluid, Non-Electrically Powered   More FDA Info for this Device
510(K) Number	K082138
Device Name	Injector, Fluid, Non-Electrically Powered
Applicant	PERFACTION, INC. 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHAN 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	07/29/2008
Decision Date	01/23/2009
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