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

    SINCLAIR SEBORRHEA EMULSION

    K Number: K050158 · Decision Oct 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    8
    Review Days
    624

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    Basic Information

    Device Name
    SINCLAIR SEBORRHEA EMULSION
    K Number
    K050158
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sinclair Pharmaceuticals, Ltd.
    Date Received
    January 25, 2005
    Decision Date
    October 11, 2006
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Sinclair Pharmaceuticals, Ltd.

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    K042722 ALOCLAIR ORAL SPRAY
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    K023046 SST SALIVA SUPPORTING TABLETS
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