SH14 HEMOCONCENTRATOR


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K081313
Device Name SH14 HEMOCONCENTRATOR
Applicant
SORIN GROUP ITALIA S.R.L.
200 west street
waltham, 
MA 
02451

Applicant Contact barry sall
Correspondent
SORIN GROUP ITALIA S.R.L.
200 west street
waltham, 
MA 
02451

Correspodent Contact barry sall
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 05/09/2008
Decision Date 11/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No