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510(k) Data Aggregation

    K Number
    K012868
    Device Name
    MICROMEDICS FIBRIJET AEROSOL APPLICATOR
    Manufacturer
    MICROMEDICS, INC.
    Date Cleared
    2001-10-29

    (63 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICROMEDICS FIBRIJET AEROSOL APPLICATOR

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

    The Micromedics FibriJet Aerosol Applicator is intended for use in applying two non-homogeneous fluids to a treatment site.

    Device Description

    Not Found

    AI/ML Overview

    This is a PMA (Premarket Approval) letter and does not contain the information requested. There are no acceptance criteria, device performance, or study details included in this document. This letter primarily focuses on the FDA's decision regarding the substantial equivalence of the Micromedics FibriJet Aerosol Applicator to legally marketed predicate devices and outlines regulatory compliance requirements.

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