FDA 510(k) Application Details - K973703

Device Classification Name	Catheter, Irrigation   More FDA Info for this Device
510(K) Number	K973703
Device Name	Catheter, Irrigation
Applicant	ALLEGIANCE HEALTHCARE CORP. 1430 WAUKEGAN RD. MCGAW PARK, IL 60085 US Other 510(k) Applications for this Company
Contact	JOSEPH A MERTIS Other 510(k) Applications for this Contact
Regulation Number	878.4200   More FDA Info for this Regulation Number
Classification Product Code	GBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/1997
Decision Date	12/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review