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

    VESTEX Apparel

    K Number: K180217 · Decision May 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    113

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    Basic Information

    Device Name
    VESTEX Apparel
    K Number
    K180217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vestagen Protective Technologies, Inc.
    Date Received
    January 25, 2018
    Decision Date
    May 18, 2018
    Product Code
    QBW
    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
    QBW Surgical Apparel With Material Claims