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ESZ — Tube, Shunt, Endolymphatic Class II

FDA Device Classification

Classification Details

Product Code
ESZ
Device Class
Class II
Regulation Number
874.3820
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K974224exmoor plasticsENDOLYMPHATIC SAC TO MASTOID T-SHUNTJanuary 27, 1998
K952227trebay medicalC-FLEX ENDOLYMPHATIC SHUNTJune 16, 1995
K897049hood laboratoriesGIBSON ENDOLYMPHATIC SHUNTMarch 16, 1990
K834094treace medicalAUSTIN ENDOLYMPH DISPERSMENT SHUNTSeptember 20, 1984