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    FDA 510(k), K813388, HEMODIALYSATE

    FDA 510(k), K813388, HEMODIALYSATE

    $89.00 USD
    $89.00 USD
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    510(K) Number: K813388
    Device Name: HEMODIALYSATE
    Manufacturer:
    Device Classification Name: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
    Regulation Number: KPO
    Classification Product Code: KXA
    Date Received: 12/02/1981
    Decision Date: 12/31/1981
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Hematology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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