FDA 510(k) Application Details - K090117

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K090117
Device Name	Needle, Hypodermic, Single Lumen
Applicant	AUTOSAFE-REFLEX INC. 1025 NINE N. DR. SUITE K ALPHARETTA, GA 30004 US Other 510(k) Applications for this Company
Contact	JOHN 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	01/21/2009
Decision Date	09/29/2009
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	N
Expedited Review