GYRUS ENT NERVE STIMULATOR


Device Classification Name

stimulator, nerve

510(k) Number K021595
Device Name GYRUS ENT NERVE STIMULATOR
Original Applicant
GYRUS ENT L.L.C.
2925 appling rd.
bartlett, 
TN 
38133

Original Contact greg sredin
Regulation Number 874.1820
Classification Product Code
ETN  
Date Received 05/15/2002
Decision Date 10/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No