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    FDA 483s for Cardiac Insight, Evoqua, MGS Germantown (Devices – Feb 2025)

    FDA 483s for Cardiac Insight, Evoqua, MGS Germantown (Devices – Feb 2025)

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Original Request: Please provide the following 5 inspection-related documents in Product Type Devices in electronic PDF format: (1) The 483(s) for the inspection of Cardiac Insight, Inc. (FEI 3010342616), located in Bellevue, Washington, United States, inspection ending 2025-02-07, with project area(s): Compliance: Devices, Postmarket Assurance: Devices; (2) The 483(s) for the inspection of Evoqua Water Technologies LLC (FEI 3006029151), located in South Windsor, Connecticut, United States, inspection ending 2025-02-04, with project area(s): Compliance: Devices, Postmarket Assurance: Devices. (3) The 483(s) for the inspection of MGS Germantown A Division of MGS Group NA, Inc. (FEI 3011179004), located in Germantown, Wisconsin, United States, inspection ending 2025-01-31, with project area(s): Compliance: Devices, Postmarket Assurance: Devices. ETC
    Tags: MedTech, 483, 2025
    • 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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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