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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Visual Reinforcement Audiometric
510(k) Number K880259
Device Name VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV
Applicant
Colorado Hearing Systems, Inc.
P.O. Box 20324
Denver,  CO  80220
Applicant Contact ARLAN D ROGERS/CR
Correspondent
Colorado Hearing Systems, Inc.
P.O. Box 20324
Denver,  CO  80220
Correspondent Contact ARLAN D ROGERS/CR
Regulation Number874.1050
Classification Product Code
LYN  
Date Received01/22/1988
Decision Date 04/03/1989
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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