BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    WATER JEL FIRE BLANKET

    K Number: K800064 · Decision Mar 25, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    74

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    Basic Information

    Device Name
    WATER JEL FIRE BLANKET
    K Number
    K800064
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5180
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Trilling Resources, Ltd.
    Date Received
    January 11, 1980
    Decision Date
    March 25, 1980
    Product Code
    FPY
    Advisory Committee
    General Hospital
    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
    FPY Sheet, Burn

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    Other Clearances by Trilling Resources, Ltd.

    K Number Device Name
    K864841 WATER-JEL(R) BURN DRESSING