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FDA Registration Medical Devices Establishment

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Published date: December 29, 2022
  • Location: Arkansas City, Kansas, United States
FDA Registration Medical Devices Establishment
FDA Registration Medical Devices Establishment
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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