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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K962012
Device Name ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
Applicant
ETHICAL HEARING INSTRUMENTS
90 FLEET ST.
PORTSMOUTH,  NH  03801
Applicant Contact DAVID J DELAGE
Correspondent
ETHICAL HEARING INSTRUMENTS
90 FLEET ST.
PORTSMOUTH,  NH  03801
Correspondent Contact DAVID J DELAGE
Regulation Number874.1050
Classification Product Code
EWO  
Date Received05/23/1996
Decision Date 08/21/1996
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
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