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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name face plate hearing aid
510(k) Number K933038
Device Name GOLD AF MODULE, ITE
Applicant
ELECTONE, INC.
1124 FLORIDA CENTRAL PKWY.
LONGWOOD,  FL  32750
Applicant Contact JIM NEE
Correspondent
ELECTONE, INC.
1124 FLORIDA CENTRAL PKWY.
LONGWOOD,  FL  32750
Correspondent Contact JIM NEE
Regulation Number874.3300
Classification Product Code
LRB  
Date Received04/28/1993
Decision Date 08/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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