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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 K882555
Device Name ANOTRON(R) INCONTINENCE CONTROL SYSTEM
Applicant
Biosonics, Inc.
14000d Commerce Pkwy.
Mt.Laurel,  NJ  08054
Applicant Contact RICHARD G JONES
Correspondent
Biosonics, Inc.
14000d Commerce Pkwy.
Mt.Laurel,  NJ  08054
Correspondent Contact RICHARD G JONES
Regulation Number876.2040
Classification Product Code
KPN  
Date Received06/21/1988
Decision Date 08/30/1988
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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