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

    WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS

    K Number: K885309 · Decision Feb 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    58
    Applicant Total
    125
    Review Days
    408

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    Basic Information

    Device Name
    WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS
    K Number
    K885309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    December 28, 1988
    Decision Date
    February 9, 1990
    Product Code
    ESW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ESW Prosthesis, Esophageal

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