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

    LAKE DISPOSABLE PROBE COVER

    K Number: K880578 · Decision Mar 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    15
    Review Days
    50

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    Basic Information

    Device Name
    LAKE DISPOSABLE PROBE COVER
    K Number
    K880578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Lake Medical Products, Inc.
    Date Received
    February 10, 1988
    Decision Date
    March 31, 1988
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Lake Medical Products, Inc.

    K Number Device Name
    K943162 LAKE STAGEZERO(TM) AIR FLOTATION BED
    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
    K875383 LAKE CATHETER CARE KITS (MODIFICATION)
    Search all 15 clearances from Lake Medical Products, Inc. →