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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, electronic noise (for audiometric testing)
510(k) Number K811790
Device Name OCTOTOXIC SCREENER
Applicant
WESTERN ADVANCED TECHNOLOGY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
WESTERN ADVANCED TECHNOLOGY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.1120
Classification Product Code
ETS  
Date Received06/24/1981
Decision Date 07/15/1981
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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