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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K771769
Device Name TINNITUS MASKERS, MODELS S564&S574
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 Number874.3400
Classification Product Code
KLW  
Date Received09/19/1977
Decision Date 01/03/1978
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
Predetermined Change
Control Plan Authorized		 No
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