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

    MEDPOR OCULAR SCREW AND ACCEOSSORIES

    K Number: K971583 · Decision Jun 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    61

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    Basic Information

    Device Name
    MEDPOR OCULAR SCREW AND ACCEOSSORIES
    K Number
    K971583
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Porex Technologies Corp.
    Date Received
    April 30, 1997
    Decision Date
    June 30, 1997
    Product Code
    MQU
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQU Ocular Peg

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    Other Clearances by Porex Technologies Corp.

    K Number Device Name
    K922489 MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA