FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES


Device Classification Name

dialysate concentrate for hemodialysis (liquid or powder)

510(k) Number K030497
Device Name FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
Applicant
FRESENIUS MEDICAL CARE
95 hayden ave.
lexington, 
MA 
02420

Applicant Contact art eilinsfeld
Correspondent
FRESENIUS MEDICAL CARE
95 hayden ave.
lexington, 
MA 
02420

Correspodent Contact art eilinsfeld
Regulation Number 876.5820
Classification Product Code
KPO  
Date Received 02/19/2003
Decision Date 05/20/2003
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

Recalls CDRH Recalls