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    FDA 510K (K863131) PIK POCKET (IRRIGATING TIP)

    FDA 510K (K863131) PIK POCKET (IRRIGATING TIP)

    $89.00 USD
    $89.00 USD
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    Device Classification Name    Unit, Oral Irrigation
    510(k) Number    K863131
    Device Name    PIK POCKET (IRRIGATING TIP)
    Applicant    TELEDYNE, INC.
    Regulation Number    872.6510
    Classification Product Code    EFS  
    Date Received    08/15/1986
    Decision Date    08/26/1986
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    Dental

    Total pages: 20
    Fully redacted pages: 3
    Content pages: 17

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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