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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 K871787
Device Name ENURESIS ALARM
Applicant
Dilorenzo Engineering Co.
109 Pearl Light Cir.
Ft. Washington,  MD  20744
Applicant Contact DANIEL J DILORENZO
Correspondent
Dilorenzo Engineering Co.
109 Pearl Light Cir.
Ft. Washington,  MD  20744
Correspondent Contact DANIEL J DILORENZO
Regulation Number876.2040
Classification Product Code
KPN  
Date Received05/06/1987
Decision Date 08/10/1987
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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