FDA 510(k) Application Details - K071567

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K071567
Device Name	Needle, Hypodermic, Single Lumen
Applicant	AUTOSAFE-REFELX INC. 1025 NINE NORTH DR., SUITE K ALPHARETTA, GA 30004 US Other 510(k) Applications for this Company
Contact	JOHN D STEPHENS 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	06/07/2007
Decision Date	09/14/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review