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

    STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)

    K Number: K864311 · Decision Nov 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    3
    Review Days
    23

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    Basic Information

    Device Name
    STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)
    K Number
    K864311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Clinitech, Inc.
    Date Received
    November 3, 1986
    Decision Date
    November 26, 1986
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Clinitech, Inc.

    K Number Device Name
    K896367 STERILE SURGICAL DRAPES AND SHEETS
    K895667 STERILE SURGICAL GOWN