1 0

    FDA 510K (K895259) PIK POCKET(R), MODEL PP-3

    FDA 510K (K895259) PIK POCKET(R), MODEL PP-3

    $89.00 USD
    $89.00 USD
    Sale Sold out

    Device Classification Name    Unit, Oral Irrigation
    510(k) Number    K895259
    Device Name    PIK POCKET(R), MODEL PP-3
    Applicant    TELEDYNE WATER PIK
    Regulation Number    872.6510
    Classification Product Code    EFS  
    Date Received    06/02/1989
    Decision Date    11/01/1989
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    Dental

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

    View full details