Posted On: 07/13/2016 2:23:01 PM
Post# of 1782
****** $MFST IN LAST STEP IN 510(K) HERE IS THE FLOWCHART...*******
As you can see the final step is demonstrating Substantial Equivalence (SE)
Well while searching through the 510(k) premarket notifications on the FDA site, I came across this:
As you can see the final step is demonstrating Substantial Equivalence (SE)
Well while searching through the 510(k) premarket notifications on the FDA site, I came across this:
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