Medical Devices. Overview. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).
Verb. 1. enfilade-rake or be in a position to rake with gunfire in a lengthwise direction. rake-sweep the length of; The gunfire raked the coast. Translations.
Here again, existing Pella doors and windows with built-in blinds can be retrofitted if they were manufactured in 2005 or later. Pellaâs Insynctive products are controlled by a handheld remote, or they can be tied into other lighting and connected-home systems using a Z-Wave to ethernet hub.