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

    PEC IMPLANT

    K Number: K913768 · Decision Feb 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    7
    Applicant Total
    7
    Review Days
    165

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    Basic Information

    Device Name
    PEC IMPLANT
    K Number
    K913768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Applied Biomaterial Technologies
    Date Received
    August 22, 1991
    Decision Date
    February 3, 1992
    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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