DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT


Device Classification Name

dialyzer, high permeability with or without sealed dialysate system

510(k) Number K021732
Device Name DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT
Original Applicant
DIDECO S.P.A.
195 west st.
waltham, 
MA 
02451 -1163

Original Contact barry sall
Regulation Number 876.5860
Classification Product Code
KDI  
Date Received 05/24/2002
Decision Date 11/04/2002
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