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510(k) Data Aggregation

    K Number
    K030172
    Device Name
    SMALL HIGH SPEED MOTOR DRILL SYSTEM
    Manufacturer
    BRASSELER USA I, L.P.
    Date Cleared
    2003-04-03

    (76 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRASSELER USA I, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE SMALL HIGH SPEED DRICE SYSTEM IS INTENDED FOR RAPID DISSEETTON OF BONE, BOPLASTICS AND BIOMATERIALS DURING NEUROSURGICAL, ENT AND MAXILLOFACIAL SURGICAL PROCEDURES
    Device Description
    SMALL MIGH SPEED MOTOR DRILL SYSTEMS
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    K Number
    K983223
    Device Name
    DENTAL STERLIZATION TRAY/CASSETTE
    Manufacturer
    BRASSELER USA I, L.P.
    Date Cleared
    1999-01-14

    (122 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRASSELER USA I, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is intended to enclose medical devices that are to be sterilized in a health care facility. The tray is intended to allow steam to penetrate to the enclosed medical devices.
    Device Description
    Not Found
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    K Number
    K955140
    Device Name
    2.0 X 6MM SCREW
    Manufacturer
    BRASSELER USA I, L.P.
    Date Cleared
    1996-01-05

    (53 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRASSELER USA I, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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