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

    CRYOTRON 2 CRYOTHERAPY DEVICE

    K Number: K030281 · Decision Aug 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    205

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    Basic Information

    Device Name
    CRYOTRON 2 CRYOTHERAPY DEVICE
    K Number
    K030281
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryonic Medical North America
    Date Received
    January 27, 2003
    Decision Date
    August 20, 2003
    Product Code
    MLY
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MLY Vapocoolant Device

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