BEUDAMED
    FDA 510(k) FDA unclassified Unknown 🇺🇸 United States

    GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT

    K Number: K890107 · Decision Oct 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    9
    Review Days
    286

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    Basic Information

    Device Name
    GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
    K Number
    K890107
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Unknown
    Applicant
    Premium Plastics, Inc.
    Date Received
    January 11, 1989
    Decision Date
    October 24, 1989
    Product Code
    FRO
    Advisory Committee
    Unknown
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Premium Plastics, Inc.

    K Number Device Name
    K953226 PULM O2 SUCTION CATHETER TRAYS
    K950851 GENT-L-KARE TRACHEOSTOMY TRAYS
    K950850 GENT-L-KARE LACERATION TRAYS
    K943740 ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
    K893135 GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
    K850285 GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY
    K800440 STERILE SPONGE BOWLS
    K771448 STERILE SUTURE REMOVAL KIT