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    FDA 510(k) K211318, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs, by Smith Nephew Medical Limited

    FDA 510(k) K211318, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs, by Smith Nephew Medical Limited

    $1,540.58 USD
    $1,540.58 USD
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    Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
    510(k) Number: K211318
    Device Name: PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
    Applicant: Smith Nephew Medical Limited
    Regulation Number: 878.4780
    Classification Product Code: OMP
    Date Received: 04/30/2021
    Decision Date: 01/05/2022
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: General & Plastic Surgery
    510k Review Panel: General & Plastic Surgery

    Total number of pages: 2,084
    Fully redacted pages: 1,462
    Content pages: 622

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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