BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ROSS EMBRACE PUMP SET

    K Number: K011467 · Decision Aug 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    4
    Review Days
    88

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    Basic Information

    Device Name
    ROSS EMBRACE PUMP SET
    K Number
    K011467
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ross Products
    Date Received
    May 14, 2001
    Decision Date
    August 10, 2001
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Ross Products

    K Number Device Name
    K972437 ROSS ENTERAL FEEDING TUBE
    K950017 FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM
    K951429 FLEXIFLO 6.1 ENTERAL NUTRITION PUMP