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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 K946323
Device Name UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
Applicant
UNITRON INDUSTRIES, INC.
3555 WALNUT ST.
P.O. BOX 5010
PORT HURON,  MI  48061 -5010
Applicant Contact JERRY G JOHNSON
Correspondent
UNITRON INDUSTRIES, INC.
3555 WALNUT ST.
P.O. BOX 5010
PORT HURON,  MI  48061 -5010
Correspondent Contact JERRY G JOHNSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/29/1994
Decision Date 01/30/1995
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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