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

    PC-MINI

    K Number: K934367 · Decision Nov 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    0
    Applicant Total
    169
    Review Days
    62

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    Basic Information

    Device Name
    PC-MINI
    K Number
    K934367
    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
    GE Medical Systems
    Date Received
    September 7, 1993
    Decision Date
    November 8, 1993
    Product Code
    JYD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JYD Chisel, Mastoid

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