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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 K872522
Device Name BED ALERT
Applicant
Nite Train-R Enterprises, Inc.
P.O. Box 1170
Newberg,  OR  97132
Applicant Contact JOE W SNYDER
Correspondent
Nite Train-R Enterprises, Inc.
P.O. Box 1170
Newberg,  OR  97132
Correspondent Contact JOE W SNYDER
Regulation Number876.2040
Classification Product Code
KPN  
Date Received06/25/1987
Decision Date 01/19/1988
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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