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FDA Product Code

FDA Product Code ESZ — Clearance Directory

Device Class
Class II
Assigned Panel
Ear, Nose, Throat
21 CFR Citation
874.3820

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K974224 ENDOLYMPHATIC SAC TO MASTOID T-SHUNT Exmoor Plastics , Ltd. 1998-01-27 Traditional PDF ↗
K952227 C-FLEX ENDOLYMPHATIC SHUNT Trebay Medical Corp. 1995-06-16 Traditional PDF ↗
K897049 GIBSON ENDOLYMPHATIC SHUNT Hood Laboratories 1990-03-16 Traditional PDF ↗
K834094 AUSTIN ENDOLYMPH DISPERSMENT SHUNT Treace Medical, Inc. 1984-09-20 Traditional PDF ↗

Product code ESZ · Class II · Ear, Nose, Throat. Data: openFDA.