CKHEMO, MODEL CKHEMO VERSION 1.0


Device Classification Name

system, dialysate delivery, single patient

510(k) Number K992255
Device Name CKHEMO, MODEL CKHEMO VERSION 1.0
Applicant
CSAM, INC.
1890 14th st.
bettendorf, 
IA 
52722

Applicant Contact yoobong kim
Correspondent
CSAM, INC.
1890 14th st.
bettendorf, 
IA 
52722

Correspodent Contact yoobong kim
Regulation Number 876.5820
Classification Product Code
FKP  
Date Received 07/06/1999
Decision Date 11/30/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No