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

    num Vapocoolant

    K Number: K202782 · Decision Dec 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    num Vapocoolant
    K Number
    K202782
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    623 Medical, LLC
    Date Received
    September 22, 2020
    Decision Date
    December 21, 2020
    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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