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    FDA Form 483s for Penner Mfg, Angiodynamics, APEX Dental Sleep Lab, Nightware, and JoGo Health – Medical Devices

    FDA Form 483s for Penner Mfg, Angiodynamics, APEX Dental Sleep Lab, Nightware, and JoGo Health – Medical Devices

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Original Request: Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of Penner Mfg Inc, located at 102 Grant St Ste A, Aurora, NE, 68818-3200, United States, inspection ending 2/11/2025 (FEI 1922538). The 483 (in electronic format) for the Medical Devices inspection of Angiodynamics, Inc., located at 603 Queensbury Ave, Queensbury, NY, 12804-7619, United States, inspection ending 1/10/2025 (FEI 1319211). The 483 (in electronic format) for the Medical Devices inspection of APEX Dental Sleep Lab LLC, located at 7863 La Mesa Blvd Ste 204, La Mesa, CA 91942-6708, United States, inspection ending 2/22/2024 (FEI 3012716038). The 483 (in electronic format) for the Medical Devices inspection of Nightware, located at 8900 Excelsior Blvd, Hopkins, MN 55343-3412, United States, inspection ending 7/1/2024 (FEI 3017660607). The 483 (in electronic format) for the Medical Devices inspection of JoGo Health, located at 991 US Highway 22 Ste 200, Bridgewater, NJ 08807-2957, United States, inspection ending 7/30/2024 (FEI 3016735640).
    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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