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

    CONTURA DISPOS. SURG. FACE MASK

    K Number: K813078 · Decision Dec 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    19
    Review Days
    46

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    Basic Information

    Device Name
    CONTURA DISPOS. SURG. FACE MASK
    K Number
    K813078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Convertors Div., American Pharmaseal
    Date Received
    November 2, 1981
    Decision Date
    December 18, 1981
    Product Code
    FXX
    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
    FXX Mask, Surgical

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    K802919 ISO-BAC INSTRUMENT WRAP
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