BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    SST SALIVA SUPPORTING TABLETS

    K Number: K023046 · Decision Dec 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    15
    Applicant Total
    8
    Review Days
    81

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    Basic Information

    Device Name
    SST SALIVA SUPPORTING TABLETS
    K Number
    K023046
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinclair Pharmaceuticals, Ltd.
    Date Received
    September 12, 2002
    Decision Date
    December 2, 2002
    Product Code
    LED
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LED Stains, Chemical Solution

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