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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 K844636
Device Name SENTRY SIGNAL ENURESIS ALARM SYSTEM
Applicant
Conklin Technology, Inc.
1483 Stratford Ave.
Stratford,  CT  06497
Applicant Contact DAVID J RIORDAN
Correspondent
Conklin Technology, Inc.
1483 Stratford Ave.
Stratford,  CT  06497
Correspondent Contact DAVID J RIORDAN
Regulation Number876.2040
Classification Product Code
KPN  
Date Received11/28/1984
Decision Date 04/03/1985
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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