FDA 510(k) Application Details - K041280

Device Classification Name	Injector, Fluid, Non-Electrically Powered   More FDA Info for this Device
510(K) Number	K041280
Device Name	Injector, Fluid, Non-Electrically Powered
Applicant	FELTON INTERNATIONAL, INC. 200 NE MULBERRY SUITE 200 LEE'S SUMMIT, MO 64086 US Other 510(k) Applications for this Company
Contact	JIM STANLEY 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	05/13/2004
Decision Date	06/24/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review