FDA 510(k) Application Details - K132383

Device Classification Name	Catheter, Nephrostomy   More FDA Info for this Device
510(K) Number	K132383
Device Name	Catheter, Nephrostomy
Applicant	GYRUS ACMI, INC. 136 TURNPIKE RD. SOUTHBOROUGH, MA 01772 US Other 510(k) Applications for this Company
Contact	NEIL KELLY Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2013
Decision Date	02/04/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review