FDA 510(k) Application Details - K123766

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K123766
Device Name	Syringe, Piston
Applicant	NOVO NORDISK INC. P.O. BOX 846 PLAINSBORO, NJ 08536 US Other 510(k) Applications for this Company
Contact	LOIS KOTKOSKIE, PH. D Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2012
Decision Date	08/15/2013
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