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

    SERIM DISINTEK GTA 2.1%, MODEL: 5164

    K Number: K083295 · Decision Mar 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    27
    Review Days
    126

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    Basic Information

    Device Name
    SERIM DISINTEK GTA 2.1%, MODEL: 5164
    K Number
    K083295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Serim Research Corp.
    Date Received
    November 10, 2008
    Decision Date
    March 16, 2009
    Product Code
    JOJ
    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
    JOJ Indicator, Physical/Chemical Sterilization Process

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