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    K Number
    K960859
    Device Name
    MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
    Manufacturer
    POREX TECHNOLOGIES CORP. OF GEORGIA
    Date Cleared
    1996-05-29

    (89 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    POREX TECHNOLOGIES CORP. OF GEORGIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The MEDPOR® Ocular Peg and Sleeve and Accessories consist of two HDPE (High Density Polyethylene) Pegs, and an HDPE Sleeve with the necessary associated manual surgical instruments. The pegs and sleeve will be sold as a package, supplied sterile. All other components will be supplied separately, non-sterile. The associated surgical instruments include an Ocular Implant Clamp for holding the implant during the procedure, a sleeve driver for screwing the sleeve into the implant, and three drill bits for drilling the hole for the peg or peg and sleeve.
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