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

    WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION

    K Number: K003402 · Decision May 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    8
    Review Days
    181

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    Basic Information

    Device Name
    WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
    K Number
    K003402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Welcon, Inc.
    Date Received
    November 1, 2000
    Decision Date
    May 1, 2001
    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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    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION

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    HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE

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    HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE

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    Other Clearances by Welcon, Inc.

    K Number Device Name
    K973734 STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
    K971764 WELCON HUE-VU URINARY DRAINAGE BAG
    K912869 WOMEN AND INFANT'S DELIVERY PACK
    K904158 ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
    K894397 WELCON LIGHT HANDLE
    K830359 STERILE CATHERIZATION PROCEDURE TRAYS
    K813027 STERILE IRRIGATING SYRINGES, KITS,TRAY