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510(k) Data Aggregation

    K Number
    K000960
    Device Name
    BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900
    Manufacturer
    BARZELL-WHITMORE MAROON BELLS, INC.
    Date Cleared
    2000-05-26

    (63 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARZELL-WHITMORE MAROON BELLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K972672
    Device Name
    BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY
    Manufacturer
    BARZELL-WHITMORE MAROON BELLS, INC.
    Date Cleared
    1997-07-29

    (13 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARZELL-WHITMORE MAROON BELLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use in adult males with known or suspected prostate cancer.
    Device Description
    This device is an adjustable support and manipulation apparatus and system for transrectal ultrasound imaging probes. Provides pre-insertion fixation of ultrasound imaging probes, gross- and fine-adjustment capabilities, and lateral probe advancement in precise incremental units. Reusable, non-sterile. Materials: Delrin and Aluminum.
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