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510(k) Data Aggregation

    K Number
    K033391

    Validate with FDA (Live)

    Device Name
    MEDICAL MAGGOTS
    Manufacturer
    RONALD A. SHERMAN
    Date Cleared
    2004-01-12

    (81 days)

    Product Code
    NQK
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K072438,K102827,K123449
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for "Medical Maggots" and does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms substantial equivalence to a predicate device for specific indications for use, but it does not detail any performance metrics or clinical study results.

    Therefore, I cannot provide the requested information based on the provided text.

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