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510(k) Data Aggregation

    K Number
    K003402
    Device Name
    WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
    Manufacturer
    WELCON, INC.
    Date Cleared
    2001-05-01

    (181 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELCON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K973734
    Device Name
    STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
    Manufacturer
    WELCON, INC.
    Date Cleared
    1998-02-05

    (128 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELCON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sterile water and sterile saline are indicated for device irrigation only. The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.
    Device Description
    The Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation are individual, single-use 4 oz. (120 ml.) cups of fluid intended to be used for irrigation. The individual container consists of a plastic cup with a heat-sealed, adhesive-backed foil lid.
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    K Number
    K971764
    Device Name
    WELCON HUE-VU URINARY DRAINAGE BAG
    Manufacturer
    WELCON, INC.
    Date Cleared
    1997-07-29

    (77 days)

    Product Code
    KNX
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELCON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Welcon Hue-Vu™ Urinary drainage Bag is indicated for use for the collection of urine when used with an indwelling catheter.
    Device Description
    The Welcon Hue-Vu™ Urinary Drainage Bag is a 2000 ml capacity vented vinyl urine collection receptacle intended to be used with an indwelling catheter. The bag has a hanging hook at the top, and is equipped with a sampling port near the catheter connector. The inlet tubing has an anti-reflux valve to prevent backflow. A vent allows air to escape the bag as urine enters. A Hue-Vu™ color strip label is affixed to the front of the bag, and is used to compare and record the color of the urine collected in the bag.
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