BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Bactisure Wound Lavage

    K Number: K192349 · Decision Jan 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    147

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    Basic Information

    Device Name
    Bactisure Wound Lavage
    K Number
    K192349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5475
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Next Science, LLC
    Date Received
    August 29, 2019
    Decision Date
    January 23, 2020
    Product Code
    FQH
    Advisory Committee
    General Hospital
    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
    FQH Lavage, Jet

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    Other Clearances by Next Science, LLC

    K Number Device Name
    K203446 TorrentX Wound Wash
    K203835 MIS Solution
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