The OTC and Prescription FDA 510K Dual-Use Integration Application project submitted by Shenzhen Reanny Medical Device Management Consulting Co. on 1 August 2019 achieved zero-defect clearance on 1 November 2019, with a full 3-month timeframe from submission to clearance. This is our fourth case in two years to receive a zero-defect clearance for 510K. This represents not only an honour, but also a strength. In 2019, we have continuously represented our clients to submit more than twenty 510K registration projects. Because of focus, we are professional; because of professionalism, we are excellent; because of excellence, we are leading.


