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

    COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL

    K Number: K113660 · Decision May 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    142

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    Basic Information

    Device Name
    COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
    K Number
    K113660
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cryotherapy Products, Inc.
    Date Received
    December 13, 2011
    Decision Date
    May 3, 2012
    Product Code
    LKX
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKX Device, Thermal, Hemorrhoids

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