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

    UNNA BOOT DRESSING W/CALAMINE

    K Number: K883224 · Decision Jan 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    8
    Review Days
    160

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    Basic Information

    Device Name
    UNNA BOOT DRESSING W/CALAMINE
    K Number
    K883224
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Graham-Field, Inc.
    Date Received
    July 29, 1988
    Decision Date
    January 5, 1989
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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