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510(k) Data Aggregation

    K Number
    K992286
    Device Name
    DERMAFREEZE
    Date Cleared
    2000-01-21

    (198 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    RHEALM PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DermaFreeze™ is a vapocoolant intended for topical application for the control of pain associated with minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), injections, and contusions.
    Device Description
    DermaFreeze™ is a vapocoolant
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