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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 K881299
Device Name ITE HEARING AID, EAR-TRONICS MODELS: M1-M23
Applicant
EAR-TRONICS, INC.
1403 CAPE CORAL PKWY.
CAPE CORAL,  FL  33904
Applicant Contact ROBERT L HOOPER
Correspondent
EAR-TRONICS, INC.
1403 CAPE CORAL PKWY.
CAPE CORAL,  FL  33904
Correspondent Contact ROBERT L HOOPER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/28/1988
Decision Date 08/05/1988
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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