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

    SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE

    K Number: K884295 · Decision Nov 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE
    K Number
    K884295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Saybrex Intl., Inc.
    Date Received
    October 12, 1988
    Decision Date
    November 8, 1988
    Product Code
    LGM
    Advisory Committee
    General Hospital
    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
    LGM Chamber, Patient Isolation

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