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

    SHIRT, OPERATING, SURGICAL

    K Number: K894599 · Decision Aug 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    SHIRT, OPERATING, SURGICAL
    K Number
    K894599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Miroz Industries Co.
    Date Received
    July 20, 1989
    Decision Date
    August 11, 1989
    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 Miroz Industries Co.

    K Number Device Name
    K894284 GOWN, OPERATING, SURGICAL