Moosey., re the 510k, I think PB has kept to the expected max time frame and it may come sooner. This from the announcement on the 2nd July 2015.
"The FDA has agreed to extend our due date by 180 days.
However, we are confident we will complete the dossier sooner than their allocated time".
There is more in the 4E to like as well, however will leave that till I have had a good read.
Cheers
Moosey., re the 510k, I think PB has kept to the expected max...
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