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

    MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL

    K Number: K952677 · Decision Aug 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    19
    Review Days
    70

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    Basic Information

    Device Name
    MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
    K Number
    K952677
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Porex Surgical, Inc.
    Date Received
    June 12, 1995
    Decision Date
    August 21, 1995
    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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    K040851 MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
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