J
Julie O
A device comes in three different sizes, small, medium, and large, because patients come in different sizes, too.
The device is 510(k) exempt, but if it were the subject of a 510(k), I'd think that all three sizes could be included in the same 510(k). Similarly, I'd think that all three sizes could be covered in a single device listing.
Would I be correct?
The device is 510(k) exempt, but if it were the subject of a 510(k), I'd think that all three sizes could be included in the same 510(k). Similarly, I'd think that all three sizes could be covered in a single device listing.
Would I be correct?