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

    POWERFLEX PEC IMPLANT

    K Number: K973729 · Decision Dec 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    7
    Applicant Total
    14
    Review Days
    85

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    Basic Information

    Device Name
    POWERFLEX PEC IMPLANT
    K Number
    K973729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hanson Medical, Inc.
    Date Received
    September 30, 1997
    Decision Date
    December 24, 1997
    Product Code
    MIC
    Advisory Committee
    Ear, Nose, Throat
    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
    MIC Implant, Muscle, Pectoralis

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