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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 K902993
Device Name SYSTEMS FLOW 2000
Applicant
Universal Hydrotech, Inc.
C/O Charles I. Rose & Co, Inc.
1963 Rock St., Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
Universal Hydrotech, Inc.
C/O Charles I. Rose & Co, Inc.
1963 Rock St., Suite #17
Mountain View,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number876.5220
Classification Product Code
KPL  
Date Received07/09/1990
Decision Date 12/24/1990
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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