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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
510(k) Number K802870
Device Name RION ELECTRO-PALATOGRAPH MODEL DP-01
Applicant
Kindel & Anderson
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kindel & Anderson
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LEZ  
Date Received11/14/1980
Decision Date 12/17/1980
Decision Substantially Equivalent (SESE)
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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