SOLCART B


Device Classification Name

dialysate concentrate for hemodialysis (liquid or powder)

510(k) Number K072760
Device Name SOLCART B
Applicant
B. BRAUN MEDIZINTECHNOLOGIE GMBH
901 marcon boulevard
allentown, 
PA 
18109 -9341

Applicant Contact tracy maddock
Correspondent
B. BRAUN MEDIZINTECHNOLOGIE GMBH
901 marcon boulevard
allentown, 
PA 
18109 -9341

Correspodent Contact tracy maddock
Regulation Number 876.5820
Classification Product Code
KPO  
Date Received 09/28/2007
Decision Date 01/29/2008
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