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

    POREX(TM) PROSTHESIS, CHIN, INTERNAL

    K Number: K863941 · Decision Oct 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    15
    Review Days
    14

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    Basic Information

    Device Name
    POREX(TM) PROSTHESIS, CHIN, INTERNAL
    K Number
    K863941
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Porex Medical
    Date Received
    October 10, 1986
    Decision Date
    October 24, 1986
    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 Porex Medical

    K Number Device Name
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    K873044 POREX OTOLOGY INSTRUMENTS
    K872947 POREX QUALITY PLASTIC SURGERY INSTRUMENTS
    K863943 POREX(TM) EYE SPHERE IMPLANT
    K863946 POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT
    K870154 POREX(TM) TISSUE EXPANDER
    K870182 POREX(TM) MALAR IMPLANT
    K870257 POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.
    K863939 POREX(TM) EAR PROSTHESIS
    K863942 POREX(TM) NOSE PROSTHESIS
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