FDA 510(k) Application Details - K052286

Device Classification Name	Catheter, Irrigation   More FDA Info for this Device
510(K) Number	K052286
Device Name	Catheter, Irrigation
Applicant	THE CATHETER EXCHANGE, INC. 16633 VENTURA BLVD. SUITE 735 ENCINO, CA 91436 US Other 510(k) Applications for this Company
Contact	GEORGE P TEITELBAUM 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	08/22/2005
Decision Date	10/21/2005
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