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

    HEMO-DE

    K Number: K822784 · Decision Nov 5, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    52

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    Basic Information

    Device Name
    HEMO-DE
    K Number
    K822784
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Pmp Industries
    Date Received
    September 14, 1982
    Decision Date
    November 5, 1982
    Product Code
    KEM
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KEM Agent, Clearing

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