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

    DECONTAMINATING KIT, SKIN: M291

    K Number: K894455 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    21

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    Basic Information

    Device Name
    DECONTAMINATING KIT, SKIN: M291
    K Number
    K894455
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Dept. of the Army
    Date Received
    July 25, 1989
    Decision Date
    August 15, 1989
    Product Code
    MAC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MAC Decontamination Kit

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    K901760 LITTER, FOLDING RIGID POLE, DECONTAMINABLE