BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SMARTSPONGE SYSTEM

    K Number: K071355 · Decision May 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    9

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    Basic Information

    Device Name
    SMARTSPONGE SYSTEM
    K Number
    K071355
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clearcount Medical Solutions, Inc.
    Date Received
    May 15, 2007
    Decision Date
    May 24, 2007
    Product Code
    LWH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWH Counter, Sponge, Surgical

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