FDA 510(k) Application Details - K003741

Device Classification Name	Injector, Fluid, Non-Electrically Powered   More FDA Info for this Device
510(K) Number	K003741
Device Name	Injector, Fluid, Non-Electrically Powered
Applicant	EQUIDYNE SYSTEMS, INC. 11770 BERNARDO PLAZA CT. SUITE 351 SAN DIEGO, CA 92128 US Other 510(k) Applications for this Company
Contact	JIM BARLEY 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	12/04/2000
Decision Date	06/01/2001
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