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

    CARBOMEDICS HANDLE

    K Number: K962154 · Decision Aug 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    11
    Applicant Total
    22
    Review Days
    84

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    Basic Information

    Device Name
    CARBOMEDICS HANDLE
    K Number
    K962154
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.3935
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carbomedics, Inc.
    Date Received
    June 4, 1996
    Decision Date
    August 27, 1996
    Product Code
    DTJ
    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
    DTJ Holder, Heart-Valve, Prosthesis

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