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    FDA 510(k) K221249 Submission for LIP-1F (TRIOS 5) by 3Shape

    FDA 510(k) K221249 Submission for LIP-1F (TRIOS 5) by 3Shape

    $69.00 USD
    $69.00 USD
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    Original Request: We are reaching out to request disclosure of the submission made for product [Trade/Device Name]: LIP-1F (TRIOS 5) following to 510(k) Summary #K221249, In order to better understand the logic behind the performance tests, and how these corresponded with FDA expectations. Especially in the context of the following topics: Discussion of Differences, Non-Clinical Data, Performance Testing.
    Tags: MedTech, 510(k), 2024
    • 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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