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

    BALDUR NON-STERILE COTTON SPONGES

    K Number: K974347 · Decision Feb 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    6
    Review Days
    83

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    Basic Information

    Device Name
    BALDUR NON-STERILE COTTON SPONGES
    K Number
    K974347
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baldur Systems Corp.
    Date Received
    November 19, 1997
    Decision Date
    February 10, 1998
    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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    GAUZE, SPONGES, CAT # 11-003

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