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Re: JNdouble1 post# 139042

Wednesday, 05/23/2018 1:29:31 PM

Wednesday, May 23, 2018 1:29:31 PM

Post# of 329207
It is just a paperwork exercise for Biel

and FDA. The previously submitted 510K

is what they are using according to the press release and FDA.

They simply had to add the back study information to the previously

submitted 510K and send it to the FDA.

Think that paperwork took more than a day or two or three?

I don't.

Negative people in my life get banished, they have shown me exactly who I do not want to hang around with, and who I don't want to be.