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510(k) Data Aggregation

    K Number
    K990278
    Device Name
    DAUM NEUROCUT NEUROBIOPSYNEEDLE
    Manufacturer
    DAUM CORP.
    Date Cleared
    1999-03-30

    (61 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daum NeuroCut NeuroBiopsyNeedle is designed for biopsy of the soft tissue in the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle.
    Device Description
    Daum NeuroCut NeuroBiopsy Needle
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    K Number
    K981320
    Device Name
    DAUM BONE BIOPSY SET
    Manufacturer
    DAUM CORP.
    Date Cleared
    1998-06-29

    (80 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DAUM Bone Biopsy Set is intended for the biopsy of bone tissue. The DAUM Bone Biopsy Set is also a low-artifact-instrument designed to be used in the MRI for the above purpose.
    Device Description
    The DAUM Bone Biopsy Set consists of a working tube, stylet, power drill drive, manual drill and an ejector drift. The drill is supplied as a disposable unit. All of the other components of the set are supplied as reusable products.
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    K Number
    K974631
    Device Name
    DAUM NEUROBIOPSY NEEDLE
    Manufacturer
    DAUM CORP.
    Date Cleared
    1998-03-09

    (87 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daum NeuroBiopsy Needle is designed for biopsy of the soft tissues in the brain. The Daum NeuroBiopsy Needle is also a low-artifact-instrument designed to be used in the MRI for the above purpose.
    Device Description
    Not Found
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    K Number
    K974574
    Device Name
    DAUM NEUROPUNCTURE NEEDLE
    Manufacturer
    DAUM CORP.
    Date Cleared
    1998-03-06

    (88 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daum NeuroPuncture Needle is designed for use in open and percutaneous sur cal pr of the brain i.e., punctures, biopsies and instillation of substrates. The Doum NeuroPunchia Needle is also a low-artifact-instrument designed to be used in the MRI for the above purposes.
    Device Description
    Daum NeuroPuncture Needle
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    K Number
    K974575
    Device Name
    DAUM ASPIRATIONBIOPSY NEEDLE
    Manufacturer
    DAUM CORP.
    Date Cleared
    1998-03-06

    (88 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daum AspirationBiopsy Needle is intended for use in precutaneous or open surgical biopsies, including, but not limited to biopsy of breast, kidney, liver, lymph nodes, and prostate. The Daum AspirationBiopsy Needle is also a low-artifact-instrument designed to be used in the MRI for the above purposes.
    Device Description
    Daum AspirationBiopsy Needle
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    K Number
    K974576
    Device Name
    DAUM BIOPSYGUN
    Manufacturer
    DAUM CORP.
    Date Cleared
    1998-03-06

    (88 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daum BiopsyGun is deigned to automatically perform a biopsy of soft tissues. The Daum BiopsyGun is also a low-artifact-instrument designed to be used in the MRI for the above purpose.
    Device Description
    Not Found
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