Would say what you submit has to be exactly how it appears in labs..
They've designed the prototypes - put them in labs - had feedback saying yes this configuration works..
Whats the point in getting FDA approval for the robotics then clients saying actually this size or shape doesn't work in a commercial lab
Thats my read on it anyways.
hopefully this one takes less time.
Merry Xmas everyone
Ann: US FDA 510k Submitted for APAS Independence, page-4
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