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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, prescription
510(k) Number K953049
Device Name Z24
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
ESD  
Date Received06/30/1995
Decision Date 08/15/1995
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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