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

    SHAPE TO FIT COMPRESSION WEAR

    K Number: K101906 · Decision Sep 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    71

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    Basic Information

    Device Name
    SHAPE TO FIT COMPRESSION WEAR
    K Number
    K101906
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tsung Hau Technology Co., Ltd.
    Date Received
    July 8, 2010
    Decision Date
    September 17, 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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