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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, Master
510(k) Number K860171
Device Name VOROBA PROGRAMMABLE AUDITORY COMPARATOR
Applicant
Voroba Technologies Assoc.
14853 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact VOROBA, PH.D.
Correspondent
Voroba Technologies Assoc.
14853 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact VOROBA, PH.D.
Regulation Number874.3330
Classification Product Code
KHL  
Date Received01/17/1986
Decision Date 05/02/1986
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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