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    FDA 510(k), K000442, ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648

    FDA 510(k), K000442, ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648

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    510(k) Number    K000442
    Device Name    ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648
    Device Classification Name    Drape, Surgical D6650,D6651, D66XX
    Applicant    MEDICAL CONCEPTS DEVELOPMENT, INC.
    Regulation Number    878.4370
    Classification Product Code    KKX  
    Date Received    02/10/2000
    Decision Date    04/24/2001
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    General & Plastic Surgery

    Total pages: 1121
    Fully redacted pages: 915
    Content pages: 206

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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