LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K042400
    Device Name
    MUCOTROL CONCENTRATED ORAL GEL WAFER
    Manufacturer
    BELCHER PHARMACEUTICALS, INC.
    Date Cleared
    2004-11-24

    (82 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BELCHER PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MUCOTROL™ CONCENTRATED ORAL GEL WAFER HAS A MECHANICAL ACTION INDICATED FOR THE MANAGEMENT OF PAIN AND RELIEF OF PAIN, BY ADHERING TO THE MUCOSAL SURFACE OF THE MOUTH, SOOTHING ORAL LESIONS OF VARIOUS ETIQLOGIES, INCLUDING: ORAL MUCOSITIS/STOMATITIS (MAY BE CAUSED BY CHEMOTHERAPY OR RADIOTHERAPY), IRRITATION DUE TO ORAL SURGERY AND TRAUMATIC ULCERS CAUSED BY BRACES OR ILL FITTING DENTURES OR DISEASES. ALSO INDICATED FOR DIFFUSE APTHOUS ULCERS.
    Device Description
    Belcher Pharmaceutical's Mucotrol™ concentrated oral gel wafer is compressed powder, presented as 2200 mg slow dissolving wafer. This combination of substances, when slowly dissolved in the mouth, due to saliva, forms a protective layer over the oral mucosa.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1