FDA 510(k), K100451, GAMCATH HIGH FLOW DOLPHIN

510(k) Number:    K100451
Device Name: GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
Device Classification Name: Catheter, Hemodialysis, Non-Implanted
Applicant: GAMBRO RENAL PRODUCTS, INC.
Regulation Number:    876.5540
Classification Product Code:    MPB  
Date Received:    02/17/2010
Decision Date:    12/21/2010
Decision:    Substantially Equivalent (SESE)
Regulation Medical Specialty:    Gastroenterology/Urology