Watsonregmd
Registered
Hi all,
just wanted to ask which is the procedure to change a predicate device as part of a 510k clearance. Can the original predicate be replaced for another device? can we add a new predicate or reference device on top of the original predicate device that was used?
Which will be the procedure to conduct these changes?
thanks a lot!
WC
just wanted to ask which is the procedure to change a predicate device as part of a 510k clearance. Can the original predicate be replaced for another device? can we add a new predicate or reference device on top of the original predicate device that was used?
Which will be the procedure to conduct these changes?
thanks a lot!
WC