BEUDAMED
    FDA 510(k) FDA not classified Substantially Equivalent 🇺🇸 United States

    WATER JEL BURN KIT

    K Number: K952561 · Decision Jul 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    42

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    Basic Information

    Device Name
    WATER JEL BURN KIT
    K Number
    K952561
    Device Class
    FDA not classified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Water-Jel Technologies, Inc.
    Date Received
    June 2, 1995
    Decision Date
    July 14, 1995
    Product Code
    LRR
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRR First Aid Kit With Drug

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