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

    URINARY CATHETER CARE SET

    K Number: K780735 · Decision Jun 13, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    2
    Review Days
    43

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    Basic Information

    Device Name
    URINARY CATHETER CARE SET
    K Number
    K780735
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Shield Laboratories, Inc.
    Date Received
    May 1, 1978
    Decision Date
    June 13, 1978
    Product Code
    FCM
    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
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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    Other Clearances by Shield Laboratories, Inc.

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