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    FDA 510(k), K843146, MICRO-TEMP PUMPS & MICRO-TEMP PADS

    FDA 510(k), K843146, MICRO-TEMP PUMPS & MICRO-TEMP PADS

    $89.00 USD
    $89.00 USD
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    510(K) Number: K843146
    Device Name: MICRO-TEMP PUMPS & MICRO-TEMP PADS
    Manufacturer:
    Device Classification Name: Pack, Hot Or Cold, Water Circulating
    Regulation Number: ILO
    Classification Product Code: KXA
    Date Received: 08/10/1984
    Decision Date: 08/17/1984
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Physical Medicine

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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