BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK

    K Number: K122717 · Decision Dec 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    5
    Review Days
    107

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    Basic Information

    Device Name
    FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
    K Number
    K122717
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tiger Medical Products, Ltd.
    Date Received
    September 5, 2012
    Decision Date
    December 21, 2012
    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 Tiger Medical Products, Ltd.

    K Number Device Name
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