FDA 510(k) Application Details - K152050

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K152050
Device Name	Needle, Hypodermic, Single Lumen
Applicant	B. BRAUN MELSUNGEN AG CARL-BRAUN STRASSE 1 MELSUNGEN 34212 DE Other 510(k) Applications for this Company
Contact	HANS-ULRICH GAUDIN 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	07/23/2015
Decision Date	03/02/2016
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