BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AMUCHINA

    K Number: K952302 · Decision Jul 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    370
    Registration Numbers
    370
    Same Product Code
    72
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    AMUCHINA
    K Number
    K952302
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6890
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amuchina Intl., Inc.
    Date Received
    May 16, 1995
    Decision Date
    July 26, 1995
    Product Code
    LRJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRJ Disinfectant, Medical Devices

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    Other Clearances by Amuchina Intl., Inc.

    K Number Device Name
    K992016 AMUKIN D
    K871583 MODIFIED LABELING FOR AMUKIN-50%
    K862928 AMUKIN-50% FOR CAPD Y-SET
    K852359 AMUCHINA/DIALYZER DISINFECTANT