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

    MEDLINE ANTI-EMBOLISM STOCKING

    K Number: K141127 · Decision Aug 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    63
    Applicant Total
    238
    Review Days
    112

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    Basic Information

    Device Name
    MEDLINE ANTI-EMBOLISM STOCKING
    K Number
    K141127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medline Industries, Inc.
    Date Received
    May 1, 2014
    Decision Date
    August 21, 2014
    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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