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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    MEMO 4D

    K Number: K180411 · Decision Mar 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    74
    Applicant Total
    61
    Review Days
    29

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    Basic Information

    Device Name
    MEMO 4D
    K Number
    K180411
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Italia S.R.L.
    Date Received
    February 15, 2018
    Decision Date
    March 16, 2018
    Product Code
    KRH
    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
    KRH Ring, Annuloplasty

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