FDA 510(k) Application Details - K162457

Device Classification Name	More FDA Info for this Device
510(K) Number	K162457
Device Name	Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
Applicant	Rocket Medical Plc 2-4 Sedling Road, Wear Industrial Estate Washington NE38 9BZ GB Other 510(k) Applications for this Company
Contact	Tracy Charlton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2016
Decision Date	11/14/2016
Decision	SEKD - SUBST EQUIV - KIT WITH DRUGS
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