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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K021595
Device Name GYRUS ENT NERVE STIMULATOR
Applicant
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact GREG SREDIN
Correspondent
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact GREG SREDIN
Regulation Number874.1820
Classification Product Code
ETN  
Date Received05/15/2002
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
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