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

    LAKE WOUND CARE/TREATMENT KIT

    K Number: K873973 · Decision Nov 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    15
    Review Days
    52

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    Basic Information

    Device Name
    LAKE WOUND CARE/TREATMENT KIT
    K Number
    K873973
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Lake Medical Products, Inc.
    Date Received
    September 29, 1987
    Decision Date
    November 20, 1987
    Product Code
    LRO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LRO General Surgery Tray

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    Other Clearances by Lake Medical Products, Inc.

    K Number Device Name
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    K922730 LAKE OSTOMY CARE SET
    K905053 STAGE ZERO AIR FLOTATION BED
    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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