BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STERILE IRRIGATING SYRINGES, KITS,TRAY

    K Number: K813027 · Decision Nov 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    40
    Applicant Total
    8
    Review Days
    23

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    Basic Information

    Device Name
    STERILE IRRIGATING SYRINGES, KITS,TRAY
    K Number
    K813027
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6960
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Welcon, Inc.
    Date Received
    October 28, 1981
    Decision Date
    November 20, 1981
    Product Code
    KYZ
    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
    KYZ Syringe, Irrigating (Non Dental)

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    Other Clearances by Welcon, Inc.

    K Number Device Name
    K003402 WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
    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