11/01/2022 Other Services
Most Class II (moderate risk) devices require a Premarket Notification 510(k) clearance from the FDA before they may be legally marketed.
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
www.itbhdg.com
https://www.itbholdingsllc.com/services/medical-devices-ppe/
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