ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS


Device Classification Name

dialysate concentrate for hemodialysis (liquid or powder)

510(k) Number K010760
Device Name ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
Original Applicant
ADVANCED RENAL TECHNOLOGIES, INC.
11838 n.e. 112th st.
kirkland, 
WA 
98033

Original Contact robin callan
Regulation Number 876.5820
Classification Product Code
KPO  
Date Received 03/13/2001
Decision Date 06/11/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No