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    FDA Documents for PowerFlow IV Port (K163001), Q160659, Q160835

    FDA Documents for PowerFlow IV Port (K163001), Q160659, Q160835

    $69.00 USD
    $69.00 USD
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    Original Request: The disclosable portions of any and all documents and records concerning the PowerFlowTM Implantable Apheresis IV Port with 9.6 Fr. ChronoFlexTM Catheter (K163001), the related pre-submission (Q160659), and the Informational Meeting request (Q160835), including but not limited to memoranda, reports, summaries, briefing documents, presentations, slide decks, reviews, analyses, meeting minutes, notes, letters, emails, facsimiles, telephone logs, etc., from January 1, 2014 to present.
    Tags: MedTech, 510(k), 2014
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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