FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K080964
Device Name FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 winter street
waltham, 
MA 
02451 -1457

Applicant Contact janet c kay
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
920 winter street
waltham, 
MA 
02451 -1457

Correspodent Contact janet c kay
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 04/04/2008
Decision Date 01/14/2009
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