If a manufacturer's medical device falls into a generic category of exempted class I devices, a premarket notification application and FDA clearance are not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list their products. 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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