DBB-05 HEMODIALYSIS DELIVERY SYSTEM


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K023509
Device Name DBB-05 HEMODIALYSIS DELIVERY SYSTEM
Original Applicant
DAVITA CLINICAL RESEARCH (TRRI)
4050 olson memorial hwy
minneapolis, 
MN 
55422

Original Contact tracy l gray
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 10/18/2002
Decision Date 10/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No