Verisante Technology Inc. V.VRS

RE:RE:RE:Verisante Technology, Inc. Announces Submission to the FDA..

[smush74]

if it was a 510(k) application around six month

 The FDA does not “approve” devices via the 510(k) process - they “clear” them for sale by determining if the applicant’s device is “Substantially Equivalent” to another 510(k) cleared device already legally marketed in the United States. Only devices that go through the Premarket Approval (PMA) process are “approved” by the FDA. Most of these are Class III devices.

They only mention talks so don't really know which direction they have to take