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

    DOLPHIN UMBILICAL CORD CLAMP

    K Number: K870446 · Decision Feb 17, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    DOLPHIN UMBILICAL CORD CLAMP
    K Number
    K870446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Andermac, Inc.
    Date Received
    February 3, 1987
    Decision Date
    February 17, 1987
    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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