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510(k) Data Aggregation

    K Number
    K955748
    Device Name
    DOYLE EXTRACTOR
    Manufacturer
    SAFETECH INTL., INC.
    Date Cleared
    1996-03-14

    (90 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFETECH INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports.
    Device Description
    The Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports. It is manufactured from polypropylene and provides a suitable leverage for extraction of right-angle needles from the skin and implanted IV port. The device contains a slot on the top blade to secure the IV tubing prior to removal of the needle.
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