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510(k) Data Aggregation

    K Number
    K974327
    Device Name
    WINGED NEEDLE HOLDER
    Manufacturer
    PHX TECHNOLOGIES CORP.
    Date Cleared
    1998-01-09

    (52 days)

    Product Code
    FHQ
    Regulation Number
    876.4730
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHX TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This winged needle holder is indicated for use in securing and positioning a hypodermic needle during the administration of a peribulbar nerve block.
    Device Description
    The winged needle holder is fabricated from polyethylene.
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    K Number
    K971123
    Device Name
    STONE EXTRACTOR
    Manufacturer
    PHX TECHNOLOGIES CORP.
    Date Cleared
    1997-06-27

    (92 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHX TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications: This instrument is indicated for use with a compatible trumpet valve during endoscopic surgery for facilitating the removal of gallstones.
    Device Description
    The stone extractor has a nominal diameter of 0.392", a tube length of 13.0" and has a scoop 0.6" long. The surface of the stone extractor is polished on the proximal 3.0" and matte finished on the remaining 10.0". The stone extractor is fabricated from 304 stainless steel.
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