LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K962688
    Device Name
    MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-07-25

    (14 days)

    Product Code
    KCF
    Regulation Number
    874.4420
    Why did this record match?
    Product Code :

    KCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Treatment of pharyngocutaneous fistulas following laryngectorny or laryngoesophagectorny. 2. Management of cervical esophageal and hypopharyngeal strictures and fistulas resulting from a variety of causes including surgery, radiation, advanced malignancy, trauma, and ingestion of caustic agents.
    Device Description
    The Montgomery Salivary Bypass Tube is a silicone tube with a funnel-shaped end for use in treating esophageal strictures and fistulas. The tube is available is sizes 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, and 20mm (outside diameter).
    Ask a Question

    Page 1 of 1