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

    FLEXIBLE MYOCARDIAL BIOPSY FORCEPS

    K Number: K883723 · Decision Dec 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    22
    Applicant Total
    190
    Review Days
    96

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    Basic Information

    Device Name
    FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
    K Number
    K883723
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4075
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cook, Inc.
    Date Received
    August 31, 1988
    Decision Date
    December 5, 1988
    Product Code
    DWZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWZ Device, Biopsy, Endomyocardial

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