BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BANDBAG, WRAP, STERILE

    K Number: K820692 · Decision May 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    14
    Applicant Total
    8
    Review Days
    52

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    Basic Information

    Device Name
    BANDBAG, WRAP, STERILE
    K Number
    K820692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Contour Fabricators, Inc.
    Date Received
    March 12, 1982
    Decision Date
    May 3, 1982
    Product Code
    MMP
    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
    MMP Cover, Barrier, Protective

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