FDA 510(k) Application Details - K131040

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K131040
Device Name	Needle, Hypodermic, Single Lumen
Applicant	B. BRAUN MELSUNGEN AG BAHNSTRASSE 42-46 FRIEDRICHSDORF, HESSE 61381 DE Other 510(k) Applications for this Company
Contact	KARIN LUBBERS 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	04/15/2013
Decision Date	07/15/2013
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