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

    KIT PAK IRRIGATION TRAY

    K Number: K900148 · Decision Apr 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    13
    Review Days
    102

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    Basic Information

    Device Name
    KIT PAK IRRIGATION TRAY
    K Number
    K900148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Kit Pak, Inc.
    Date Received
    January 11, 1990
    Decision Date
    April 23, 1990
    Product Code
    EYN
    Advisory Committee
    Gastroenterology, Urology
    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
    EYN Tray, Irrigation, Sterile

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    Other Clearances by Kit Pak, Inc.

    K Number Device Name
    K942959 KIT PAK WET SALINE DRESSING
    K941499 KIT PAK DRESSING CHANGE TRAY
    K932310 KIT PAK INCONTINENT SKIN CARE KIT
    K934080 URINARY DRAINAGE BAG
    K931013 FOLEY CATHETER TRAY
    K923905 WOUND DRESSING KIT
    K924051 KIT PAK I.V. START KIT
    K923906 FOLEY INSERTION TRAY
    K922051 KIT PAK'S FLUSHING KIT
    K925281 KIT PAK URINARY CARE SUPPLIES
    Search all 13 clearances from Kit Pak, Inc. →