FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB

Device Classification Name

dialysate concentrate for hemodialysis (liquid or powder)

510(k) Number K071387
Device Name FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 winter street
waltham, 
MA 
02451

Applicant Contact janet c kay
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
920 winter street
waltham, 
MA 
02451

Correspodent Contact janet c kay
Regulation Number 876.5820
Classification Product Code
KPO  
Date Received 05/18/2007
Decision Date 06/15/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls