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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 K862683
Device Name BIOSOICS SPHINCTER TRAINING SYSTEM
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 Received07/15/1986
Decision Date 11/12/1986
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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