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510(k) Data Aggregation

    K Number
    K082856
    Device Name
    CARAPASTE ORAL WOUND DRESSING
    Manufacturer
    MCGRATH PHARMACEUTICALS, INC.
    Date Cleared
    2008-10-15

    (16 days)

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

    MCGRATH PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CARAPASTE® Oral Wound Dressing forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lessions associated with oral surgery.
    Device Description
    CARAPASTE ® Oral Wound Dressing, Sucralfate HCl Topical Paste, is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of hydrochloric acid. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers lesions where gastric acid or local wound bed acidity is not available or is inconsistently present. CARAPASTE ® Oral Wound Dressing may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucralfate with strong acid, the polymerized sucralfate self-buffers to a pH of approximately 3.5.
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