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    FDA 510(k), K080383, AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING

    FDA 510(k), K080383, AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING

    $89.00 USD
    $89.00 USD
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    510(K) Number: K080383
    Device Name: AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
    Manufacturer:
    Device Classification Name: Dressing, Wound, Drug
    Regulation Number:
    Classification Product Code: FRO
    Date Received: 02/12/2008
    Decision Date: 05/02/2008
    Regulation Medical Specialty:

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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