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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 K971855
Device Name POTTY PAL AND FOREVER-DRY
Applicant
Digital Applications, Inc.
275 E. 300 S
Santaquin,  UT  84655
Applicant Contact D. LYNN SHEPPARD
Correspondent
Digital Applications, Inc.
275 E. 300 S
Santaquin,  UT  84655
Correspondent Contact D. LYNN SHEPPARD
Regulation Number876.2040
Classification Product Code
KPN  
Date Received05/20/1997
Decision Date 08/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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