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

    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

    K Number: K990584 · Decision Apr 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    270
    Applicant Total
    2
    Review Days
    59

    Basic Information

    Device Name
    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
    K Number
    K990584
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BROADLINE MEDICAL INDUSTRIES
    Date Received
    February 23, 1999
    Decision Date
    April 23, 1999
    Product Code
    EFQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EFQ Gauze/Sponge, Internal

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