DeviceClearance

Product code EPP— Ear, Nose, Throat

THE DENVER SPLINT

Classification name
Splint, Nasal
Device class
Class 1
Regulation
21 CFR 874.5800
Advisory panel
Ear, Nose, Throat
Total cleared
15
First cleared
Most recent

Market context for product code EPP

FDA has cleared 15 devices under product code EPP between 1979 and 1994, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code EPP

Recent clearances under product code EPP

Data sourced from openFDA. This site is unofficial and independent of the FDA.