Every establishment that has to register for the devices you sell - as manufacturer, contract manufacturer, specification developer, relabeler or repacker - with each fiscal year's registration and fee recorded from FDA's own confirmation. FDA's fiscal year runs October 1 to September 30.
A device is cleared to ship for a fiscal year only when its 510(k) and device listing are on file and every establishment that makes, specifies or relabels it is registered for that fiscal year.