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    FDA 510K (K091736), SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2

    FDA 510K (K091736), SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2

    $524.34 USD
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    Device Classification Name    Container, Sharps
    510(k) Number    K091736
    Device Name    SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
    Applicant    DANIELS CORPORATION PTY, INC.
    Regulation Number    880.5570
    Classification Product Code    MMK  
    Date Received    06/11/2009
    Decision Date    10/30/2009
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    General Hospital

    Total pages: 495  
    Fully redacted pages: 293  
    Content pages: 202 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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