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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K012113
Device Name INDWELLING FECAL MANAGEMENT SYSTEM
Applicant
BOWEL MANAGEMENT SYSTEMS, LLC
7992 CASTEWAY DR.
INDIANAPOLIS,  IN  46250
Applicant Contact COLLEEN J HITTLE
Correspondent
BOWEL MANAGEMENT SYSTEMS, LLC
7992 CASTEWAY DR.
INDIANAPOLIS,  IN  46250
Correspondent Contact COLLEEN J HITTLE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/06/2001
Decision Date 05/03/2002
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
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