FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K992275
Device Name FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
Applicant
FRESENIUS USA, INC.
110 mason cr
concord, 
CA 

Applicant Contact virginia singer
Correspondent
FRESENIUS USA, INC.
110 mason cr
concord, 
CA 

Correspodent Contact virginia singer
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 07/07/1999
Decision Date 08/04/1999
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