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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K923074
Device Name DANPLEX SCREENING AUDIOMETER
Applicant
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236 -6221
Applicant Contact ALFRED C COATS
Correspondent
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236 -6221
Correspondent Contact ALFRED C COATS
Regulation Number874.1050
Classification Product Code
EWO  
Date Received06/25/1992
Decision Date 09/23/1992
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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