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

    SELF-CONTAINED SURGICAL SLUSH FREEZER

    K Number: K913777 · Decision Sep 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    42

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    Basic Information

    Device Name
    SELF-CONTAINED SURGICAL SLUSH FREEZER
    K Number
    K913777
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Taylor Corp.
    Date Received
    August 14, 1991
    Decision Date
    September 25, 1991
    Product Code
    JRM
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JRM Freezer

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