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Friday, November 06, 2015 7:36:53 PM
“I am pleased the agency has completed this step in streamlining the regulatory requirements for making available to Americans, the same safe drug-free pain relief option enjoyed in other countries around the world,” said Andrew J. Whelan, President. Earlier this year, in response to our request for information regarding the regulatory status of ActiPatch®, the FDA confirmed that it falls within the classification regulation that is the subject of the reclassification. We believe that the reclassification will contribute to an efficient review of our submitted evidence in our 510(k) premarket notification. The reclassification to Class II includes a provision for the FDA’s evaluation of our request for over-the-counter market clearance.
http://www.bielcorp.com/bioelectronics-applauds-fda-final-rule-reclassification/
So that means the review process had already started and it wasn't start on the final order, so sometime in August, otherwise how do you confirm if you have not look at the info..
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