1 0

    FDA 510(k), K845036, TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600

    FDA 510(k), K845036, TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600

    $89.00 USD
    $89.00 USD
    Sale Sold out
    510(K) Number: K845036
    Device Name: TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600
    Manufacturer:
    Device Classification Name: Tissue Expander And Accessories
    Regulation Number:
    Classification Product Code: LCJ
    Date Received: 12/27/1984
    Decision Date: 06/26/1985
    Regulation Medical Specialty:

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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