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    FDA 510(K) K093065, FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000

    FDA 510(K) K093065, FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000

    $1,705.30 USD
    $1,705.30 USD
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    Device Classification Name    Pump, Infusion, Insulin Bolus
    510(k) Number    K093065
    Device Name    FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
    Applicant    CALIBRA MEDICAL, INC.
    Regulation Number    880.5725
    Classification Product Code    OPP  
    Subsequent Product Code    LZG  
    Date Received    09/30/2009
    Decision Date    01/20/2010
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    General Hospital

    Total pages: 5,255
    Fully redacted pages: 4,299
    Content pages: 956

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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