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FDA Registration Medical Devices
Description
Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the FDA. However, additional requirements apply.
ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
https://www.itbhdg.com/medical-devices-registration/
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services | other