Innovation Pharmaceuticals Inc (IPIX)

[SitTight]

Substantial equivalence means that the new device is as safe and effective as the predicate.
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device.

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k#:~:text=Substantial%20equivalence%20means%20that%20the,and%20effective%20as%20the%20predicate.