FDA 510(k) Application Details - K994218

Device Classification Name	System, Peritoneal, Automatic Delivery   More FDA Info for this Device
510(K) Number	K994218
Device Name	System, Peritoneal, Automatic Delivery
Applicant	MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. MARKHAM, ONTARIO L6E 1A5 CA Other 510(k) Applications for this Company
Contact	MAHESH A GARWAL Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	FKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/1999
Decision Date	02/10/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review