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Reanny Medical Devices Management Consulting Co., Ltd.

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0755-27391220

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020-82513196

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Assisted a customer in Guangzhou in obtaining zero replacement dental product FDA510 (k)

Congratulations to Rui Enni for assisting a customer in Guangzhou in obtaining 510 (k) zero replacement for their 3D additive printed denture base resin, which took 2 and a half months to obtain certification;

This application starts with assisting the enterprise in planning various product testing and obtaining Small Business (SBD) certification; And expedite the submission of eStar by the end of fiscal year 2024, successfully obtaining 510 (k) approval with zero defects after 2 and a half months. Saved the enterprise from the increased 510 (k) application fee due to the 2025 fiscal year

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0755-27391220

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020-82513196

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reanny@reanny.com