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    FDA 510(k), K090750, RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581

    FDA 510(k), K090750, RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581

    $669.00 USD
    $669.00 USD
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    510(K) Number: K090750
    Device Name: RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
    Manufacturer: RESTORATIVE THERAPIES INC.
    Device Classification Name: Stimulator, Neuromuscular, External Functional
    Regulation Number: 882.5810
    Classification Product Code: GZI
    Date Received: 03/20/2009
    Decision Date: 08/05/2009
    Regulation Medical Specialty: Neurology

    291 pages (662 of 953 original pages are fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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