FDA 510(k) Application Details - K073596

Device Classification Name	Catheter, Umbilical Artery   More FDA Info for this Device
510(K) Number	K073596
Device Name	Catheter, Umbilical Artery
Applicant	NEOMED, INC. 717 LAKEGLEN DR. SUWANEE, GA 30024 US Other 510(k) Applications for this Company
Contact	PENNY NORTHCUTT 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	12/21/2007
Decision Date	02/22/2008
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