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510(k) Data Aggregation

    K Number
    K970372
    Device Name
    GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
    Manufacturer
    PRECISION ENDOSCOPY OF AMERICA, INC.
    Date Cleared
    1997-03-11

    (39 days)

    Product Code
    FDF
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION ENDOSCOPY OF AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These endoscope nozzle replacement kits are intended for use in replacing the nozzle on 43 models of Olympus America, Inc. gastroscopes and colonoscopes.
    Device Description
    Each kit includes 6 nozzles, three set screws, sealant, and the necessary tools (#1 screw driver, tweezers, and magnifying glass) to replace the nozzle. Each kit will include only the nozzle size(s) and set screw size(s) appropriate for use with the Olympus of America, Inc. endoscope models currently being used by the purchaser.
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