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

    GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER

    K Number: K893135 · Decision Jun 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
    K Number
    K893135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Premium Plastics, Inc.
    Date Received
    April 25, 1989
    Decision Date
    June 22, 1989
    Product Code
    JOL
    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
    JOL Catheter And Tip, Suction

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    Other Clearances by Premium Plastics, Inc.

    K Number Device Name
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    K890107 GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
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