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

    MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION

    K Number: K904904 · Decision Mar 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    934
    Registration Numbers
    934
    Same Product Code
    183
    Applicant Total
    8
    Review Days
    140

    Basic Information

    Device Name
    MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION
    K Number
    K904904
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    GRAHAM-FIELD, INC.
    Date Received
    October 30, 1990
    Decision Date
    March 19, 1991
    Product Code
    KGX
    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
    KGX Tape And Bandage, Adhesive

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