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510(k) Data Aggregation

    K Number
    K994024
    Device Name
    EXTENDED STRAIGHT ATTACHMENT
    Date Cleared
    2000-02-03

    (69 days)

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

    TEAM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Extended Length Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.
    Device Description
    Extended Straight Attachment Disposable Trade Name: Prophy Angle
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    K Number
    K971849
    Device Name
    CYTOLOGY BRUSH
    Date Cleared
    1997-07-24

    (66 days)

    Product Code
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEAM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for use are the endocervical collection of specimens used in Pap smear, chlamydia and HPV testing.
    Device Description
    Cytology Brush
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