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510(k) Data Aggregation

    K Number
    K131661
    Device Name
    INFUSION SYRINGE SET
    Date Cleared
    2013-11-05

    (151 days)

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

    INNOVATIVE MEDICAL MANUFACTURING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.
    Device Description
    IMM 110 Infusion Syringe Set is single use product which contains disposable parts of one spike infusion set for connecting to fluid reservoir and fluid delivery, and a control syringe for delivery fluid supply from a solution bag to access device for purpose of delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation. The distal end of the set is a dual valve with 6% taper design for connecting to other access device such as needles before use. The IMM Infusion Syringe Set is provided sterile in fluid path, and to be disposed after single patient use.
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    K Number
    K090727
    Device Name
    IMM DENTAL IRRIGATION TUBING SET
    Date Cleared
    2009-08-13

    (147 days)

    Product Code
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE MEDICAL MANUFACTURING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMM™ Dental Irrigation Tubing Set is intended for providing passage of irrigating fluid from a solution reservoir to a dental handpiece.
    Device Description
    The IMM™ Dental Irrigation Tubing Set is to be used for providing passage of irrigating fluid t from a solution reservoir to a dental hand piece. The device consists of one or more inlet spikes, drip chamber, PVC plastic tubes, clamps, silicone tube, consists of only caps.
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    K Number
    K070801
    Device Name
    IMM HYPODERMIC NEEDLE SET
    Date Cleared
    2007-05-24

    (62 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE MEDICAL MANUFACTURING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMM Hypodermic Needle Set is to be used for sampling blood from or infusing fluid into body system underneath the skin.
    Device Description
    The IMM™ Hypodermic Needle Set consists of a conventional stainless steel needle, needle hub, extension tubing, clamp, and standard female 6% luer conical fitting for connection to a device contains a male luer fitting.
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