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

    LAKE CATHETER CARE KITS (MODIFICATION)

    K Number: K875383 · Decision Mar 9, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    15
    Review Days
    85

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    Basic Information

    Device Name
    LAKE CATHETER CARE KITS (MODIFICATION)
    K Number
    K875383
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Lake Medical Products, Inc.
    Date Received
    December 15, 1987
    Decision Date
    March 9, 1988
    Product Code
    KOD
    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
    KOD Catheter, Urological

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    K901835 LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)
    K902508 LAKE MALE EXTERNAL CATHETERIZATION KIT
    K902121 LAKE GASTROSTOMY TUBE
    K884127 LAKE N/G FEEDING TUBE
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    K883610 LAKE FOLEY CATHETERIZATION TRAY
    K880578 LAKE DISPOSABLE PROBE COVER
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