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

    GELCLAIR CONCENTRATED ORAL GEL

    K Number: K013056 · Decision Dec 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    8
    Review Days
    101

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    Basic Information

    Device Name
    GELCLAIR CONCENTRATED ORAL GEL
    K Number
    K013056
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinclair Pharmaceuticals, Ltd.
    Date Received
    September 11, 2001
    Decision Date
    December 21, 2001
    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
    K040950 ALOCLAIR ORAL GEL
    K024148 SALINUM, ORCLAIR
    K024367 SINCLAIR WOUND AND SKIN EMULSION
    K023046 SST SALIVA SUPPORTING TABLETS
    K023155 ALOCLAIR ORAL RINSE