FDA 510(k) Application Details - K161606

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K161606
Device Name	Syringe, Piston
Applicant	TERUMO EUROPE N.V. INTERLEUVENLAAN 40 LEUVEN 3001 BE Other 510(k) Applications for this Company
Contact	M.J. AERTS 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	06/10/2016
Decision Date	02/10/2017
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