FDA 510(k) Application Details - K083514

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K083514
Device Name	Syringe, Piston
Applicant	TERUMO EUROPE N.V. INTERLEUVENLAAN 40 RESEARCHPARK ZONE 2 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	11/26/2008
Decision Date	05/22/2009
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