HEMOCLEAN


Device Classification Name

disinfectant, dialysate delivery system

510(k) Number K023064
Device Name HEMOCLEAN
Original Applicant
KRD CO., LTD
anderson consulting intl.
7307 glouchester drive
edina, 
MN 
55435

Original Contact jeffery r shideman
Regulation Number 876.5860
Classification Product Code
NII  
Date Received 09/16/2002
Decision Date 04/06/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No