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

    STANDARD CHIN

    K Number: K983754 · Decision Nov 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    12
    Review Days
    29

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    Basic Information

    Device Name
    STANDARD CHIN
    K Number
    K983754
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical Technology Laboratories, Inc.
    Date Received
    October 22, 1998
    Decision Date
    November 20, 1998
    Product Code
    FWP
    Advisory Committee
    General, Plastic Surgery
    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
    FWP Prosthesis, Chin, Internal

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