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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K844478
Device Name HEARING AIDS MODELS IMS, ISD, ICL & IHX
Applicant
The Ite Co.
P.O. Box 2665
Seal Beach,  CA  90740
Applicant Contact GAUTHIER
Correspondent
The Ite Co.
P.O. Box 2665
Seal Beach,  CA  90740
Correspondent Contact GAUTHIER
Date Received11/19/1984
Decision Date 02/28/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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