FDA 510(k) Application Details - K071630

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K071630
Device Name	Syringe, Piston
Applicant	TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 US Other 510(k) Applications for this Company
Contact	EILEEN DORSEY 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	06/14/2007
Decision Date	07/11/2007
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