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

    LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET

    K Number: K011341 · Decision Sep 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    3
    Review Days
    142

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    Basic Information

    Device Name
    LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
    K Number
    K011341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lh Medical Products, Inc.
    Date Received
    May 2, 2001
    Decision Date
    September 21, 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 Lh Medical Products, Inc.

    K Number Device Name
    K011343 LH 500 ENTERAL FEEDING GRAVITY BAG SET
    K011340 LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT