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

    POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE

    K Number: K022665 · Decision Oct 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    61

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    Basic Information

    Device Name
    POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
    K Number
    K022665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3500
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hohenstein Enterprises, Inc.
    Date Received
    August 9, 2002
    Decision Date
    October 9, 2002
    Product Code
    KKY
    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
    KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

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