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

    ENSWELL

    K Number: K831899 · Decision Jul 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    467
    Registration Numbers
    468
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    23

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    Basic Information

    Device Name
    ENSWELL
    K Number
    K831899
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5700
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Dr. Micheal A. Sabia
    Date Received
    June 14, 1983
    Decision Date
    July 7, 1983
    Product Code
    IME
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IME Pack, Hot Or Cold, Reusable

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    Other Clearances by Dr. Micheal A. Sabia

    K Number Device Name
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