FDA 510(k) Application Details - K052034

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K052034
Device Name	Syringe, Piston
Applicant	TERUMO MEDICAL CORP. 125 BLUE BALL RD. ELKTON, MD 21921 US Other 510(k) Applications for this Company
Contact	BARBARA SMITH 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	07/28/2005
Decision Date	08/16/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review