Part 874 Subpart F—Therapeutic Devices

FDA submissions for Part 874 Subpart F—Therapeutic Devices in the Ear, Nose, Throat (EN) review panel, including product codes and regulations.

Section range: §§ 874.5220–874.5950

CFR Part: 874

Product Codes

Product CodeDevice NameRegulationClassDevices
EPNPump, Nebulizer, Manual874.522012
JPWPump, Nebulizer, Electrically Powered874.522011
KCJApplicator, Ent874.522014
KCLBlower, Powder, Ent874.522010
KCMDropper, Ent874.522011
KCNEar Wick874.522014
KCONasal Spray, Ent Delivery874.522011
KCPSyringe, Ent874.522014
LRDApplicator, Ent Drug874.522016
ETFUnit, Examining/Treatment, Ent874.5300132
EWTDevice, Antichoke, Suction874.535030
EWWDevice, Antichoke, Tongs874.537030
QXNSuction Anti-Choking Device As A Second-Line Treatment874.540021
KMAIrrigator, Powered Nasal874.555015
EPPSplint, Nasal874.5800115
KTHDevice, Anti-Stammering874.584014
PKAExternal Upper Esophageal Sphincter (Ues) Compression Device874.590022
QQGOropharyngeal Electrical Stimulator874.595021
Innolitics

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