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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 K962770
Device Name UROSURGE ACUTRAINER
Applicant
Princeton Regulatory Assoc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Applicant Contact THOMAS BECZE
Correspondent
Princeton Regulatory Assoc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Correspondent Contact THOMAS BECZE
Regulation Number876.2040
Classification Product Code
KPN  
Date Received07/16/1996
Decision Date 08/01/1996
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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