Premarket Device Notification

**Semantic type:** Intellectual Product

**Definition:** A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization).

**Synonyms:** - 510(k) - 510(k) - 510(k) - PMN - PREMARKET NOTIFICATION - Premarket Device Notification (510k) - Premarket Notification - Premarket Notification 510(K) - Premarket Notification Submission