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    FDA 510(k), K983119, ENTERO-TEST HP, MODEL #102-01

    FDA 510(k), K983119, ENTERO-TEST HP, MODEL #102-01

    $89.00 USD
    $89.00 USD
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    510(K) Number: K983119
    Device Name: ENTERO-TEST HP, MODEL #102-01
    Manufacturer: LEN ROSS
    Device Classification Name: Device, Specimen Collection
    Regulation Number: LIO
    Classification Product Code: KXA
    Date Received: 09/08/1998
    Decision Date: 03/15/1999
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Microbiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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