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

    WOMEN AND INFANT'S DELIVERY PACK

    K Number: K912869 · Decision Dec 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    8
    Review Days
    159

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    Basic Information

    Device Name
    WOMEN AND INFANT'S DELIVERY PACK
    K Number
    K912869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Welcon, Inc.
    Date Received
    June 28, 1991
    Decision Date
    December 4, 1991
    Product Code
    HFW
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HFW Clamp, Umbilical

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    Other Clearances by Welcon, Inc.

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    K973734 STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
    K971764 WELCON HUE-VU URINARY DRAINAGE BAG
    K904158 ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY
    K894397 WELCON LIGHT HANDLE
    K830359 STERILE CATHERIZATION PROCEDURE TRAYS
    K813027 STERILE IRRIGATING SYRINGES, KITS,TRAY