LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974042
    Device Name
    AMSURE CLEANSING ENEMA SET
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-12-19

    (56 days)

    Product Code
    FCE
    Regulation Number
    876.5210
    Why did this record match?
    Product Code :

    FCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON.
    Device Description
    AMSure® Cleansing Enema Set
    Ask a Question

    Page 1 of 1