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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 K000724
Device Name MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
Applicant
Medica S.R.L.
100 Main St.
Suite 120
Concord,  MA  01742
Applicant Contact JAMES DELANEY
Correspondent
Medica S.R.L.
100 Main St.
Suite 120
Concord,  MA  01742
Correspondent Contact JAMES DELANEY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/06/2000
Decision Date 03/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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