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    FDA 510(k), K073039, SPERMCHECK VASECTOMY, PRINCETON BIOMEDITECH CORP.

    FDA 510(k), K073039, SPERMCHECK VASECTOMY, PRINCETON BIOMEDITECH CORP.

    $89.00 USD
    $89.00 USD
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    510(K) Number: K073039
    Device Name: SPERMCHECK VASECTOMY
    Manufacturer: PRINCETON BIOMEDITECH CORP.
    Device Classification Name: Semen Analysis Device
    Regulation Number: 864.5220
    Classification Product Code: POV
    Date Received: 10/29/2007
    Decision Date: 01/24/2008
    Regulation Medical Specialty: Hematology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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