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    FDA 510(k), K913869, RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM

    FDA 510(k), K913869, RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM

    $89.00 USD
    $89.00 USD
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    510(K) Number: K913869
    Device Name: RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM
    Manufacturer: LINDA J JALBERT
    Device Classification Name: System, Nuclear Magnetic Resonance Imaging
    Regulation Number: LNH
    Classification Product Code: KXA
    Date Received: 08/28/1991
    Decision Date: 11/25/1991
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Radiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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