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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 K930005
Device Name DRITRAINER
Applicant
Laborie Medical Technologies, Ltd.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact MARY M MCNAMARA
Correspondent
Laborie Medical Technologies, Ltd.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact MARY M MCNAMARA
Regulation Number876.2040
Classification Product Code
KPN  
Date Received01/04/1993
Decision Date 03/03/1993
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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