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Steve43

05/29/18 12:17 PM

#139777 RE: clk5192 #139776

It all depends on how the Market interprets the PR. We will see shortly. IMO. Have a good day

jamesonkh

05/29/18 12:20 PM

#139782 RE: clk5192 #139776

Cancelled Pre-Approval-Meeting to Wait Longer for Submission-&-Approval

seven-up

05/29/18 12:28 PM

#139793 RE: clk5192 #139776

"The FDA’s response to our questions, suggestions, and instructions are more than adequate for us to proceed with the filing of the formal 510(k) Market Clearance Application”

This is an FDA statement to go ahead with the 510K nothing hard to understand and I see nothing related to a postponement.

The FDA apparently is satisfied with the information and have cleared them to move forward.

Reschedule date for WHAT? They approved the pre-submission 510K already.

Remember this is for RecoveryRX and there is also a 510K for Actipatxh for back

HORUS

05/29/18 12:29 PM

#139794 RE: clk5192 #139776

It’s great news no need for the meeting they have what they need. It’s coming soon

You know when!!!

HORUS