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    FDA 510(k), K093775, EVGUIDE TIP LOCATION SYSTEM

    FDA 510(k), K093775, EVGUIDE TIP LOCATION SYSTEM

    $89.00 USD
    $89.00 USD
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    510(K) Number: K093775
    Device Name: EVGUIDE TIP LOCATION SYSTEM
    Manufacturer:
    Device Classification Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
    Regulation Number: 880.5970
    Classification Product Code: LJS
    Date Received: 12/08/2009
    Decision Date: 07/15/2010
    Regulation Medical Specialty: General Hospital

    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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