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510(k) Data Aggregation

    K Number
    K974316
    Manufacturer
    Date Cleared
    1998-02-13

    (88 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HYDROFERA FEMORAL WICK

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

    The absorbent dressing is indicated for use in hip arthroplasty.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Hydrofera Femoral Wick." It does not contain any information about acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, rather than being cleared based on a specific performance study against pre-defined acceptance criteria.

    Therefore, I cannot provide the requested information from this document.

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