BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AMICON HEMOCONCENTRATOR SET

    K Number: K901286 · Decision May 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    20
    Review Days
    59

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    Basic Information

    Device Name
    AMICON HEMOCONCENTRATOR SET
    K Number
    K901286
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Amicon, Inc.
    Date Received
    March 20, 1990
    Decision Date
    May 18, 1990
    Product Code
    KDI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by Amicon, Inc.

    K Number Device Name
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    K895405 AMICON MINIFILTER PLUS HEMOFILTER
    K893733 CENTRICON CONCENTRATOR
    K892645 AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY
    K875121 AMICON EQUALINE FLUID BALANCE SYSTEM
    K870690 CENTRIPREP CONCENTRATOR
    K863823 AMICON DIAFILTER HEMOFILTER
    K853510 MINIFILTER HEMOFILTER
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