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

    PEC IMPLANT

    K Number: K961072 · Decision Apr 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    32

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    Basic Information

    Device Name
    PEC IMPLANT
    K Number
    K961072
    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
    Rand Scientific Corp.
    Date Received
    March 18, 1996
    Decision Date
    April 19, 1996
    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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