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

    TIGER FLAT SURGICAL MASK

    K Number: K102713 · Decision Jan 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    5
    Review Days
    127

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    Basic Information

    Device Name
    TIGER FLAT SURGICAL MASK
    K Number
    K102713
    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 20, 2010
    Decision Date
    January 25, 2011
    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
    K122717 FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
    K120690 INSULIN PEN NEEDLE
    K110697 TIGER SYRINGES AND NEEDLES
    K041311 TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)