COBE CENTRYSYSTEM 600 HG HEMODIALYZERS


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K960474
Device Name COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
Applicant
COBE RENAL CARE, INC.
1185 oak st.
lakewood, 
CO 
80215 -4407

Applicant Contact jeffrey r shiderman
Correspondent
COBE RENAL CARE, INC.
1185 oak st.
lakewood, 
CO 
80215 -4407

Correspodent Contact jeffrey r shiderman
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 02/02/1996
Decision Date 08/14/1996
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