FDA 510(k) Application Details - K974171

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K974171
Device Name	Introducer, Syringe Needle
Applicant	TEVA MEDICAL, LTD. 1510 DELP DR. KULPSVILLE, PA 19443 US Other 510(k) Applications for this Company
Contact	HARRY LEINWAND Other 510(k) Applications for this Contact
Regulation Number	880.6920   More FDA Info for this Regulation Number
Classification Product Code	KZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/1997
Decision Date	12/19/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review