FDA 510(k) Application Details - K953940

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K953940
Device Name	Syringe, Piston
Applicant	TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 US Other 510(k) Applications for this Company
Contact	ALAN B HERSHMAN 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	08/21/1995
Decision Date	05/21/1996
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