FDA 510(k) Application Details - K053413

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K053413
Device Name	Syringe, Piston
Applicant	TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 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	12/07/2005
Decision Date	04/06/2006
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