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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Applicant
Dideco S.P.A.
195 W. St.
Waltham,  MA  02451 -1163
Applicant Contact BARRY SALL
Correspondent
Dideco S.P.A.
195 W. St.
Waltham,  MA  02451 -1163
Correspondent Contact BARRY SALL
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/24/2002
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
Predetermined Change
Control Plan Authorized		 No
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