FDA 510(k) Application Details - K981630

Device Classification Name	Catheter, Umbilical Artery   More FDA Info for this Device
510(K) Number	K981630
Device Name	Catheter, Umbilical Artery
Applicant	SCHIFF & CO. 1129 BLOOMFIELD AVE. WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ANNE M CESARIO Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/1998
Decision Date	10/01/1998
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