FDA 510(k) Application Details - K130441

Device Classification Name	Catheter, Peritoneal, Long-Term Indwelling   More FDA Info for this Device
510(K) Number	K130441
Device Name	Catheter, Peritoneal, Long-Term Indwelling
Applicant	MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. MARKHAM, ONTARIO L6E 1A5 CA Other 510(k) Applications for this Company
Contact	MAHESH AGARWAL Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	FJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2013
Decision Date	04/19/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review