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510(k) Data Aggregation

    K Number
    K071470
    Device Name
    IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
    Manufacturer
    IMPLANTECH ASSOCIATES INC.
    Date Cleared
    2007-08-31

    (94 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ePTFE Sheeting is intended for use in the augmentation or repair of the soft tissue of the facial area.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ePTFE Sheeting," which is a surgical mesh. This document grants market clearance based on substantial equivalence to a predicate device.

    It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or any of the other details you are asking for.

    Therefore, I cannot provide the requested information based on this input. It's likely that such information would be found in the actual 510(k) submission document itself, not in the clearance letter.

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