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

    DISP. SURGICAL FACE MASK

    K Number: K771409 · Decision Oct 27, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    5
    Review Days
    87

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    Basic Information

    Device Name
    DISP. SURGICAL FACE MASK
    K Number
    K771409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Precept, Inc.
    Date Received
    August 1, 1977
    Decision Date
    October 27, 1977
    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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    Other Clearances by Precept, Inc.

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    K770463 MASK, SURGICAL, FACE, DISPOSABLE
    K770391 COVER, ARMBOARD, DISPOSABLE
    K770021 MASK, FACE, SURGICAL
    K760360 SHIRT, MITTEN CUFF INFANT