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    FDA 510(k) K210971, EnteraLoc Flow, by Vonco Products

    FDA 510(k) K210971, EnteraLoc Flow, by Vonco Products

    $867.89 USD
    $867.89 USD
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    Device Classification Name: Gastrointestinal Tubes With Enteral Specific Connectors
    510(k) Number: K210971
    Device Name: EnteraLoc Flow
    Applicant: Vonco Products
    Regulation Number: 876.598
    Classification Product Code: PIF
    Date Received: 03/31/2021
    Decision Date: 08/18/2021
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Gastroenterology/Urology
    510k Review Panel: Gastroenterology/Urology

    Total number of pages: 725
    Fully redacted pages: 435
    Content pages: 290

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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