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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alarm, Conditioned Response Enuresis
510(k) Number K834311
Device Name NIGHT TRAINER
Applicant
Maddak, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Maddak, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.2040
Classification Product Code
KPN  
Date Received11/25/1983
Decision Date 03/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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