FDA 510(k) Application Details - K041239

Device Classification Name	Injector, Fluid, Non-Electrically Powered   More FDA Info for this Device
510(K) Number	K041239
Device Name	Injector, Fluid, Non-Electrically Powered
Applicant	GENESIS MEDICAL TECHNOLOGY, INC. 1555 EAST FLAMINGO ROAD SUITE 155 LAS VEGAS, NV 89119 US Other 510(k) Applications for this Company
Contact	THOMAS KROENKE 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	05/11/2004
Decision Date	11/08/2004
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