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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to answer your request. The document describes a medical device (MEDPOR® Ocular Peg System and Accessories) and its components, sterilization methods, biocompatibility, and comparison to predicate devices for 510(k) submission. However, it does not include any acceptance criteria, performance data, or details of a study that proves the device meets specific criteria as you've requested.

    Therefore, I cannot generate the table or answer the questions related to acceptance criteria and study details.

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