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

    GORE-TEX BARRIER SURG. DRAPES & GOWNS

    K Number: K822641 · Decision Jan 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    163
    Review Days
    128

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    Basic Information

    Device Name
    GORE-TEX BARRIER SURG. DRAPES & GOWNS
    K Number
    K822641
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    September 1, 1982
    Decision Date
    January 7, 1983
    Product Code
    KKX
    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
    KKX Drape, Surgical, Antimicrobial

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