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510(k) Data Aggregation

    K Number
    K990906
    Device Name
    FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    1999-04-29

    (42 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K970706
    Why did this record match?
    Device Name :

    FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER

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

    Arcerial Ulcers Pressure Ulcers (Stage III-IV) Venous Ulcers Diabetic Ulcers

    Device Description

    FERRIS ... LOLLEWIC CARLY WOUND FILLER

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a wound filler product named "PolyMem PolyWic Sterile Cavity Wound Filler". This document does not contain information about acceptance criteria or a study proving the device meets said criteria. The letter primarily focuses on the regulatory clearance of the device based on its substantial equivalence to a legally marketed predicate device, its intended uses, and limitations on its labeling claims.

    Therefore, I cannot provide the requested information as it is not present in the given text.

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