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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 K862222
Device Name INEARSET IES HEARING AID
Applicant
INEARSET, INC.
P.O. BOX 29576
PARMA,  OH  44129
Applicant Contact JAMES MATTS
Correspondent
INEARSET, INC.
P.O. BOX 29576
PARMA,  OH  44129
Correspondent Contact JAMES MATTS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/11/1986
Decision Date 07/16/1986
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
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