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

    2X2 SPONGES, NON-STERILE, COTTON FILLED

    K Number: K863761 · Decision Oct 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    16
    Review Days
    29

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    Basic Information

    Device Name
    2X2 SPONGES, NON-STERILE, COTTON FILLED
    K Number
    K863761
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    The Medical Group, Inc.
    Date Received
    September 25, 1986
    Decision Date
    October 24, 1986
    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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