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    FDA 510(k), K060944, NUTRISAFE 2

    FDA 510(k), K060944, NUTRISAFE 2

    $906.86 USD
    $906.86 USD
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    510(K) Number: K060944
    Device Name: NUTRISAFE 2
    Manufacturer: VYGON CORP.
    Device Classification Name: Tube, Feeding
    Regulation Number: 876.5980
    Classification Product Code: FPD
    Date Received: 04/06/2006
    Decision Date: 09/15/2006
    Regulation Medical Specialty: Gastroenterology/Urology

    444 pages (66 of 510 original pages are fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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