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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air Conduction, Transcutaneous System
510(k) Number K040996
Device Name RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
Applicant
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Applicant Contact ALICIA E FARAGE
Correspondent
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Correspondent Contact ALICIA E FARAGE
Regulation Number874.3950
Classification Product Code
NIX  
Date Received04/16/2004
Decision Date 08/20/2004
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
Predetermined Change
Control Plan Authorized		 No
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