Bioelectronics Corp (BIEL)

[Det_Robert_Thorne]

That 10/3/2016 date appears to be section update

The 510K premarket notification has been modified on 10/3/2016.

That 10/3/16 "Page Last Updated" date appears to be some sort of update of the web pages in that FDA search section, and doesn't apply to the data in the records themselves.

Here's the link you provided to the ActiBand search:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=k022404

Click "New Search" and the blank search form shows the same 10/3/16 page updated date.

Click the "DeNovo" header to bring up that search, and the blank search form for that page also shows it was updated 10/3/16. The same is true for the "PMA", "HDE" and "Classification" search pages.

Now, go back to the 510(k) search, and perform a device search for "Aleve Direct". While the decision date is 12/22/2015, the "Page Last Updated" is still the same 10/3/16 date.

Clearly, that 10/3/2016 date is when the search page itself was updated, and that is a completely different thing from updates to the records themselves.