BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    URINARY DRAINAGE BAG

    K Number: K934080 · Decision May 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    13
    Review Days
    271

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    Basic Information

    Device Name
    URINARY DRAINAGE BAG
    K Number
    K934080
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kit Pak, Inc.
    Date Received
    August 20, 1993
    Decision Date
    May 18, 1994
    Product Code
    EYT
    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
    EYT Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile

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