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510(k) Data Aggregation

    K Number
    K971089
    Device Name
    OPPORTUNITY, INC. LACERATION TRAY
    Manufacturer
    OPPORTUNITY, INC.
    Date Cleared
    1997-09-16

    (176 days)

    Product Code
    KKX,K97
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Opportunity Inc.'s Laceration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing laceration procedures.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document does not contain the information you requested about acceptance criteria and device performance studies. This appears to be a 510(k) clearance letter from the FDA for a set of medical kits and trays, primarily focusing on regulatory compliance and substantial equivalence to previously marketed devices. It does not detail specific performance studies or acceptance criteria for the devices themselves.

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