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

    LAKE CATHETER CARE KIT

    K Number: K872750 · Decision Sep 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    15
    Review Days
    52

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    Basic Information

    Device Name
    LAKE CATHETER CARE KIT
    K Number
    K872750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Lake Medical Products, Inc.
    Date Received
    July 13, 1987
    Decision Date
    September 3, 1987
    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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    Other Clearances by Lake Medical Products, Inc.

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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
    K884128 LAKE N/G EXTENSION SET
    K883610 LAKE FOLEY CATHETERIZATION TRAY
    K880578 LAKE DISPOSABLE PROBE COVER
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