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

    IRRIGATION TRAY

    K Number: K944882 · Decision Jan 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    14
    Review Days
    101

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    Basic Information

    Device Name
    IRRIGATION TRAY
    K Number
    K944882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clinical Resources, Inc.
    Date Received
    October 3, 1994
    Decision Date
    January 12, 1995
    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 Clinical Resources, Inc.

    K Number Device Name
    K941470 TRACHEOSTOMY CARE KIT
    K944881 SKIN SCRUB TRAY
    K944879 GAUZE SPONGES
    K945021 FLUFF GAUZE SPONGE
    K945019 FLUFF GAUXZE ROLL
    K945020 FLUFF GAUZE SPONGE
    K944880 BODILY FLUID DISPOSAL KIT
    K941469 IV START KIT
    K941468 DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
    K941471 CENTRAL LINE DRESSING CHANGE TRAY
    Search all 14 clearances from Clinical Resources, Inc. →