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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613

    K Number: K092892 · Decision Aug 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    316

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    Basic Information

    Device Name
    1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613
    K Number
    K092892
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    I-Ming Sanitary Materials Co., Ltd.
    Date Received
    September 21, 2009
    Decision Date
    August 3, 2010
    Product Code
    DWL
    Advisory Committee
    General Hospital
    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
    DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

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