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    FDA 510(k), K051093, OSTEOPORE PCL SCAFFOLD

    FDA 510(k), K051093, OSTEOPORE PCL SCAFFOLD

    $89.00 USD
    $89.00 USD
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    510(K) Number: K051093
    Device Name: OSTEOPORE PCL SCAFFOLD
    Manufacturer:
    Device Classification Name: Methyl Methacrylate For Cranioplasty
    Regulation Number: 882.5300
    Classification Product Code: GXP
    Date Received: 04/28/2005
    Decision Date: 03/17/2006
    Regulation Medical Specialty: Neurology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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