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510(k) Data Aggregation

    K Number
    K960928
    Device Name
    SYRINGEFILTER
    Manufacturer
    ARBOR TECHNOLOGIES, INC.
    Date Cleared
    1997-04-04

    (393 days)

    Product Code
    BSN
    Regulation Number
    868.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARBOR TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use is the same.
    Device Description
    The revised Arbor Medical Syringefilter is as safe and effective as the original. The proposed plastic housings and membrane have passed Class VI testing as did the original housings and membrane. The proposed product is manufactured the same as the original. The method of sterilization is the same as the original version.
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    K Number
    K964283
    Device Name
    AUTOPRIME
    Manufacturer
    ARBOR TECHNOLOGIES, INC.
    Date Cleared
    1997-01-22

    (86 days)

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

    ARBOR TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Per FDA Safety Alert: Hazards of Precipitation Associated with Parental Nutrition, issued April 18, 1994, an IV filter is indicated for use when infusing either central or peripheral parenteral nutrition admixtures. Both pore sizes of filters are being offered. a 0.22um air eliminating filter for nonligid containing admixtures, and a 1.2um air eliminating filter for lipid containing admixtures.
    Device Description
    Not Found
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