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

    DYNASTY ISOLATION GOWN

    K Number: K922234 · Decision Aug 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    DYNASTY ISOLATION GOWN
    K Number
    K922234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dynatech Medical Products
    Date Received
    May 13, 1992
    Decision Date
    August 11, 1992
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by Dynatech Medical Products

    K Number Device Name
    K923188 DYNASTY IMPERVIOUS ISOLATION J-SUIT
    K923187 IMPERVIOUS ISOLATION SHOE COVERS
    K893520 DR. BOO LATEX EXAMINATION GLOVES
    K770730 PUMP, INFUSION, DYNATECH/HANDLEY