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

    MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN)

    K Number: K850177 · Decision Feb 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    14
    Review Days
    35

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    Basic Information

    Device Name
    MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN)
    K Number
    K850177
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Matrix Medica, Inc.
    Date Received
    January 17, 1985
    Decision Date
    February 21, 1985
    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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