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

    EXTENDED CHIN IMPLANT STYLE II

    K Number: K902825 · Decision Aug 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    41
    Review Days
    34

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    Basic Information

    Device Name
    EXTENDED CHIN IMPLANT STYLE II
    K Number
    K902825
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Implantech Associates, Inc.
    Date Received
    June 28, 1990
    Decision Date
    August 1, 1990
    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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    Other Clearances by Implantech Associates, Inc.

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    K071470 IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
    K052504 GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
    K052505 CALF IMPLANT, MODEL EC17-X
    K013732 GELZONE
    K012419 CONFORM SHEETING, MODEL IGEL
    K002886 IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
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