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

    NU-BREDE PACKING AND DEBRIDEMENT SPONGE

    K Number: K921983 · Decision Sep 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    53
    Review Days
    143

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    Basic Information

    Device Name
    NU-BREDE PACKING AND DEBRIDEMENT SPONGE
    K Number
    K921983
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Medical, Inc.
    Date Received
    April 28, 1992
    Decision Date
    September 18, 1992
    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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