FDA 510(k) Application Details - K063450

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K063450
Device Name	Needle, Hypodermic, Single Lumen
Applicant	SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. KEENE, NH 03431 US Other 510(k) Applications for this Company
Contact	BRIAN FARIAS 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	11/15/2006
Decision Date	01/25/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review