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    FDA 510(k), K895640, MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT

    FDA 510(k), K895640, MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT

    $89.00 USD
    $89.00 USD
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    510(K) Number: K895640
    Device Name: MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
    Manufacturer:
    Device Classification Name: Condom
    Regulation Number: 884.5300
    Classification Product Code: HIS
    Date Received: 09/19/1989
    Decision Date: 01/23/1990
    Regulation Medical Specialty: Obstetrics/Gynecology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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