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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, Air-Conduction, Prescription
510(k) Number K860170
Device Name VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID
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 Number874.3300
Classification Product Code
ESD  
Date Received01/17/1986
Decision Date 04/17/1986
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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