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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 K953646
Device Name UNITRON MODEL IKON AOHPL
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 Received08/04/1995
Decision Date 08/28/1995
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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