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    FDA 510(k), K171239, TULA Tube Delivery System

    FDA 510(k), K171239, TULA Tube Delivery System

    $89.00 USD
    $89.00 USD
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    510(K) Number: K171239
    Device Name: TULA Tube Delivery System
    Manufacturer: Pavan Sethi
    Device Classification Name: Tube, Tympanostomy
    Regulation Number: ETD
    Classification Product Code: KXA
    Date Received: 04/27/2017
    Decision Date: 06/28/2017
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Ear Nose & Throat

    102 pages (261 of 363 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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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