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

    DERMAFREEZE

    K Number: K992286 · Decision Jan 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    198

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    Basic Information

    Device Name
    DERMAFREEZE
    K Number
    K992286
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rhealm Pharmaceuticals, Inc.
    Date Received
    July 7, 1999
    Decision Date
    January 21, 2000
    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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