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

    ALOCLAIR ORAL GEL

    K Number: K040950 · Decision Jun 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    ALOCLAIR ORAL GEL
    K Number
    K040950
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinclair Pharmaceuticals, Ltd.
    Date Received
    April 12, 2004
    Decision Date
    June 21, 2004
    Product Code
    OLR
    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
    OLR Oral Wound Dressing

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    Other Clearances by Sinclair Pharmaceuticals, Ltd.

    K Number Device Name
    K050158 SINCLAIR SEBORRHEA EMULSION
    K042722 ALOCLAIR ORAL SPRAY
    K024148 SALINUM, ORCLAIR
    K024367 SINCLAIR WOUND AND SKIN EMULSION
    K023046 SST SALIVA SUPPORTING TABLETS
    K023155 ALOCLAIR ORAL RINSE
    K013056 GELCLAIR CONCENTRATED ORAL GEL