BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NOVIGUARD QUICK DRY

    K Number: K961044 · Decision Jul 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    476

    Basic Information

    Device Name
    NOVIGUARD QUICK DRY
    K Number
    K961044
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6890
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DR. NOVIS SMITH & CO., INC.
    Date Received
    March 14, 1996
    Decision Date
    July 3, 1997
    Product Code
    LRJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRJ Disinfectant, Medical Devices

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