1 0

    FDA 510(k), K061232, ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006

    FDA 510(k), K061232, ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006

    $302.83 USD
    $302.83 USD
    Sale Sold out

    510(K) Number: K061232
    Device Name: ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
    Manufacturer: ACRYMED, INC.
    Device Classification Name: dressing, wound, drug
    Regulation Number:
    Classification Product Code: FRO
    Date Received: 05/02/2006
    Decision Date: 10/06/2006

    Total pages: 168  
    Fully redacted pages: 62  
    Content pages: 106 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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