FDA 510(k) Application Details - K974233

Device Classification Name	Catheter, Irrigation   More FDA Info for this Device
510(K) Number	K974233
Device Name	Catheter, Irrigation
Applicant	LYSONIX, INC. 1170 MARK AVE. CARPINTERIA, CA 93013 US Other 510(k) Applications for this Company
Contact	RONALD F LAGERQUIST 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	11/12/1997
Decision Date	02/03/1998
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