1 0

    FDA 510(k), K883414, LARYNGOSCOPE BLADES

    FDA 510(k), K883414, LARYNGOSCOPE BLADES

    $89.00 USD
    $89.00 USD
    Sale Sold out
    510(K) Number: K883414
    Device Name: LARYNGOSCOPE BLADES
    Manufacturer:
    Device Classification Name: Laryngoscope, Rigid
    Regulation Number: 868.5540
    Classification Product Code: CCW
    Date Received: 08/15/1988
    Decision Date: 08/19/1988
    Regulation Medical Specialty: Anesthesiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

    View full details