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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 K934369
Device Name DRI SLEEPER
Applicant
LABORIE MEDICAL TECHNOLOGIES, LTD.
6415 NORTHWEST DR.
UNIT 11
MISSISSAUGA (ONTARIO),  CA L4V 1X1
Applicant Contact FRED BUFFA
Correspondent
LABORIE MEDICAL TECHNOLOGIES, LTD.
6415 NORTHWEST DR.
UNIT 11
MISSISSAUGA (ONTARIO),  CA L4V 1X1
Correspondent Contact FRED BUFFA
Regulation Number876.2040
Classification Product Code
KPN  
Date Received09/07/1993
Decision Date 11/24/1993
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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