FDA 510(k) Application Details - K053123

Device Classification Name	Catheter, Peritoneal, Long-Term Indwelling   More FDA Info for this Device
510(K) Number	K053123
Device Name	Catheter, Peritoneal, Long-Term Indwelling
Applicant	MED-CONDUIT, INC. 18 DERBY LANE TYNGSBORO, MA 01879 US Other 510(k) Applications for this Company
Contact	GERALD G BOUSQUET 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	11/07/2005
Decision Date	03/29/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review