FDA 510(k) Application Details - K131125

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K131125
Device Name	Needle, Hypodermic, Single Lumen
Applicant	YPSOMED AG BRUNNMATTSTRASSE 6 BURGDORF CH-3401 CH Other 510(k) Applications for this Company
Contact	BENJAMIN REINMANN 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	04/22/2013
Decision Date	07/05/2013
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