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

    BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)

    K Number: K131496 · Decision Jul 10, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
    K Number
    K131496
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bsn Medical, Inc.
    Date Received
    May 23, 2013
    Decision Date
    July 10, 2013
    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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    Other Clearances by Bsn Medical, Inc.

    K Number Device Name
    K123561 ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS