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    FDA 510(k), K033568, GYNECARE TVT OBTURATOR SYSTEM

    FDA 510(k), K033568, GYNECARE TVT OBTURATOR SYSTEM

    $89.00 USD
    $89.00 USD
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    510(K) Number: K033568
    Device Name: GYNECARE TVT OBTURATOR SYSTEM
    Manufacturer:
    Device Classification Name: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
    Regulation Number: 878.3300
    Classification Product Code: OTN
    Date Received: 11/12/2003
    Decision Date: 12/08/2003
    Regulation Medical Specialty: General & Plastic Surgery

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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