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    FDA 510(k) – K912061

    FDA 510(k) – K912061

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Original Request: Hello, I would like the 510(k) summary for K912061, Sigma Heparin Adsorbent. This is a class II device under 21CFR 864.5425-Multipurpose system for in vitro coagulation studies. If possible please send the summary and all applicable documentation for this 510(k). Thank you!
    • 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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