FDA 510(k) Application Details - K090959

Device Classification Name	Injector, Fluid, Non-Electrically Powered   More FDA Info for this Device
510(K) Number	K090959
Device Name	Injector, Fluid, Non-Electrically Powered
Applicant	D'ANTONIO CONSULTANTS INTERNATIONAL, INC. (DCI) 6308 FLY RD. EAST SYRACUSE, NY 13057 US Other 510(k) Applications for this Company
Contact	JOSEPH P D'ANTONIO 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	04/06/2009
Decision Date	12/24/2009
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