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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 K790064
Device Name TINNITUS DEVICES
Applicant
VICON INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VICON INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.1120
Classification Product Code
ETS  
Date Received01/15/1979
Decision Date 02/16/1979
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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