FDA 510(k) Application Details - K041178

Device Classification Name	Tubing, Fluid Delivery   More FDA Info for this Device
510(K) Number	K041178
Device Name	Tubing, Fluid Delivery
Applicant	E-Z-EM, INC. 717 MAIN ST. WESTBURY, NY 11590 US Other 510(k) Applications for this Company
Contact	JUDY HAUSER Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2004
Decision Date	07/16/2004
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