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510(k) Data Aggregation

    K Number
    K080532
    Device Name
    BENACEL, MODELS C-001, C-002 AND C-005
    Manufacturer
    UNICARE BIOMEDICAL, INC.
    Date Cleared
    2008-11-12

    (260 days)

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

    BENACEL, MODELS C-001, C-002 AND C-005

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding an administrative change to a previous substantial equivalence determination for a device called "Benacel®".

    This letter does not contain any information about:

    • Acceptance criteria for the device's performance.
    • Any study that proves the device meets acceptance criteria.
    • Details about sample sizes, data provenance, expert qualifications, ground truth, or study methodologies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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