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510(k) Data Aggregation

    K Number
    K030604
    Device Name
    PERFECT SAFETY SYRINGE
    Manufacturer
    PERFECT MEDICAL INDUSTRY CO., LTD.
    Date Cleared
    2004-04-30

    (430 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The primary intended use for the Perfect Safety Syringe is for IM/SC use only. The secondary intended use for the Perfect Safety Syringe is for needlestick protection, the device may aid in the reduction of needlestick injuries. In addition, when the syringe user breaks off the plunger, reuse of the syringe is prevented.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA, confirming the substantial equivalence of the Perfect Safety Syringe to legally marketed predicate devices. It does not contain details about specific performance studies, acceptance criteria, or the methodology of such studies.

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