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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 K842547
Device Name WET-STOP
Applicant
Palco Laboratories, Inc.
1595 Soquel Dr.
Santa Cruz,  CA  95065
Applicant Contact PAUL D LEVIN
Correspondent
Palco Laboratories, Inc.
1595 Soquel Dr.
Santa Cruz,  CA  95065
Correspondent Contact PAUL D LEVIN
Regulation Number876.2040
Classification Product Code
KPN  
Date Received07/02/1984
Decision Date 10/19/1984
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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