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

    Edwards Suture Fastening System

    K Number: K150882 · Decision Jun 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    4
    Applicant Total
    136
    Review Days
    75

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    Basic Information

    Device Name
    Edwards Suture Fastening System
    K Number
    K150882
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edwards Lifesciences, LLC
    Date Received
    April 2, 2015
    Decision Date
    June 16, 2015
    Product Code
    HCF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCF Instrument, Ligature Passing And Knot Tying

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