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    FDA 510(k), K221683, CYSTO-NEPHRO VIDEOSCOPE

    FDA 510(k), K221683, CYSTO-NEPHRO VIDEOSCOPE

    $89.00 USD
    $89.00 USD
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    510(K) Number: K221683
    Device Name: CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
    Manufacturer: Olympus Medical Systems Corporation
    Device Classification Name: Cystoscope And Accessories, Flexible/Rigid
    Regulation Number: 876.1500
    Classification Product Code: FAJ
    Date Received: 06/10/2022
    Decision Date: 01/20/2023
    Regulation Medical Specialty: Gastroenterology/Urology

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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