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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 K943318
Device Name ALL-IN-THE-EAR
Applicant
GOLDEN STATE AUDIOLOGY ASSOC.
2435 FOREST AVE.
SUITE 100
SAN JOSE,  CA  95128
Applicant Contact PAMELA L BALL
Correspondent
GOLDEN STATE AUDIOLOGY ASSOC.
2435 FOREST AVE.
SUITE 100
SAN JOSE,  CA  95128
Correspondent Contact PAMELA L BALL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/11/1994
Decision Date 09/16/1994
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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