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

    AMUKIN D

    K Number: K992016 · Decision Jan 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    5
    Review Days
    209

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    Basic Information

    Device Name
    AMUKIN D
    K Number
    K992016
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amuchina Intl., Inc.
    Date Received
    June 15, 1999
    Decision Date
    January 10, 2000
    Product Code
    LIF
    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
    LIF Dialyzer Reprocessing System

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    Other Clearances by Amuchina Intl., Inc.

    K Number Device Name
    K952302 AMUCHINA
    K871583 MODIFIED LABELING FOR AMUKIN-50%
    K862928 AMUKIN-50% FOR CAPD Y-SET
    K852359 AMUCHINA/DIALYZER DISINFECTANT