FDA 510(k) Application Details - K042917

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K042917
Device Name	Needle, Hypodermic, Single Lumen
Applicant	EMERGO GROUP, INC. 2519 MCMULLEN BOOTH RD. SUITE 510-295 CLEARWATER, FL 33761 US Other 510(k) Applications for this Company
Contact	RENE VAN DE ZANDE Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2004
Decision Date	04/22/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review