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Nonprescription sunglasses remain subject to regulations such as those identified as "general controls", which are applicable to all class I medical devices, and impact resistant lens requirements.
ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577
https://www.fda.itbhdg.com/product/medical-devices/
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