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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 K864448
Device Name THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM)
Applicant
Biosonics, Inc.
1500 Walnut St.
Philadelphia,  PA  19102
Applicant Contact RICHARD G JONES
Correspondent
Biosonics, Inc.
1500 Walnut St.
Philadelphia,  PA  19102
Correspondent Contact RICHARD G JONES
Regulation Number876.2040
Classification Product Code
KPN  
Date Received11/12/1986
Decision Date 02/06/1987
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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