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510(k) Data Aggregation

    K Number
    K050134
    Device Name
    ICC INSULIN SAFEPRO SAFETY SYRINGE
    Date Cleared
    2005-04-05

    (74 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORMOSA MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The primary indicated use for the 1cc Insulin SafePro* Safety Syringe is for aspirating and injecting insulin fluid. The secondary indicated use for the 1cc Insulin SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
    Device Description
    The 1cc Insulin SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries. Other than scale graduation for use with U-100 strength insulin, the 1cc Insulin SafePro* Safety Syringe is essentially identical to the legally marketed 1cc SafePro* Safety Syringe in design and materials of construction.
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    K Number
    K031830
    Device Name
    SAFEPRO PLUS SAFETY SYRINGE
    Date Cleared
    2003-08-05

    (53 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORMOSA MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The primary indicated use for the SafePro* Plus Safety Syringe is for general purpose use in aspirating and injecting fluid. The secondary indicated use for the SafePro* Plus Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
    Device Description
    The SafePro* Plus Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.
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    K Number
    K022063
    Device Name
    SAFEPRO SAFETY SYRINGE
    Date Cleared
    2002-08-29

    (65 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORMOSA MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The primary indicated use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid. The secondary indicated use for the 1cc SafePro * Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
    Device Description
    The 1cc SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature which may aid in the reduction of the risk of accidental needlestick injuries.
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