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

    SPONGETRAC

    K Number: K964181 · Decision Feb 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    131

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    Basic Information

    Device Name
    SPONGETRAC
    K Number
    K964181
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgitrac Corp.
    Date Received
    October 18, 1996
    Decision Date
    February 26, 1997
    Product Code
    MRL
    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
    MRL Scale, Sponge, Surgical, Electrically-Powered