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510(k) Data Aggregation

    K Number
    K992817
    Device Name
    ANTIBACTERIAL ADHESIVE BANDAGE
    Manufacturer
    WILLIAM FEINSTEIN & ASSOCIATES, INC.
    Date Cleared
    1999-11-05

    (77 days)

    Product Code
    FRO,MXE
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILLIAM FEINSTEIN & ASSOCIATES, INC.

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

    Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help prevent infection with minor cuts and scrapes.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document is solely focused on the FDA's communication regarding the substantial equivalence determination for an "Antibacterial Adhesive Bandage." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details for a device.

    The letters are:

    • An FDA letter from November 5, 1999, confirming the "Antibacterial Adhesive Bandage" is substantially equivalent to legally marketed predicate devices.
    • A subsequent FDA letter from November 15, 2021, informing William Feinstein & Associates, Inc. of an administrative change, specifically updating the product code for the same device.

    Therefore, I cannot extract the requested information from the provided text.

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