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

    PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5

    K Number: K863671 · Decision Oct 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    14

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    Basic Information

    Device Name
    PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5
    K Number
    K863671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Samco Industries, Inc.
    Date Received
    September 19, 1986
    Decision Date
    October 3, 1986
    Product Code
    KNX
    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
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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    Other Clearances by Samco Industries, Inc.

    K Number Device Name
    K853839 PENNINE LINK TUBING