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

    URINE SPECIMEN COLLECTING DEVICE

    K Number: K772133 · Decision Nov 28, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    9
    Applicant Total
    14
    Review Days
    14

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    Basic Information

    Device Name
    URINE SPECIMEN COLLECTING DEVICE
    K Number
    K772133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Kendall Research Center
    Date Received
    November 14, 1977
    Decision Date
    November 28, 1977
    Product Code
    FCN
    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
    FCN Urinary Drainage Collection Kit, For Indwelling Catheter

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    Other Clearances by Kendall Research Center

    K Number Device Name
    K802225 TENDER-SORB DRAIN SPONGES
    K781357 T.E.D. SEQUENTIAL COMPRESSION SLEEVES
    K780408 MICRONET LIGHT DRESSING SPONGE
    K780062 CATHETER/HEMOSTATIC/GERIATRIC
    K780120 ANESTHESIA TRAY, CAUDAL
    K772134 SYRINGE, IRRIGATION, PRE-FILLED
    K771655 CURITY PEAKOMETER
    K771079 CURITY IRRIGATION TRAY
    K771452 CONFORM STRETCH BANDAGE (5SIZES)
    K771563 CONFORM ELASTIC NETTING
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