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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Assistive Listening
510(k) Number K934805
Device Name HEARIT
Applicant
Je Liss & Co., Inc.
5665 N. Camino Estrellas
Tucson,  AZ  85718
Applicant Contact LORIN W SURPLESS
Correspondent
Je Liss & Co., Inc.
5665 N. Camino Estrellas
Tucson,  AZ  85718
Correspondent Contact LORIN W SURPLESS
Regulation Number874.3320
Classification Product Code
LZI  
Date Received10/07/1993
Decision Date 02/07/1994
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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