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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 K935915
Device Name WET SENSE
Applicant
EDSON CORP.
24015 CREEK WOOD DR.
SPRING,  TX  77389
Correspondent
EDSON CORP.
24015 CREEK WOOD DR.
SPRING,  TX  77389
Regulation Number876.2040
Classification Product Code
KPN  
Date Received12/09/1993
Decision Date 05/13/1994
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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