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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonic Irrigation System
510(k) Number K941279
Device Name LOWER BOWEL EVACUATION SYSTEM
Applicant
Tiller Mind Body, Inc.
2204 NW Loop 410 #2c
San Antonio,  TX  78230
Applicant Contact JERI C TILLER
Correspondent
Tiller Mind Body, Inc.
2204 NW Loop 410 #2c
San Antonio,  TX  78230
Correspondent Contact JERI C TILLER
Regulation Number876.5220
Classification Product Code
KPL  
Date Received03/16/1994
Decision Date 10/12/1995
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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