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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Communication, Non-Powered
510(k) Number K840112
Device Name SPEECH TEACHER
Applicant
Joseph A. Resnick
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Joseph A. Resnick
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3700
Classification Product Code
ILP  
Date Received01/09/1984
Decision Date 03/22/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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