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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 K970482
Device Name TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
Applicant
Srs Intl.
1625 K St. NW
Suite 1000
Washington,  DC  20006
Applicant Contact MICHAEL G FARROW, PH.D.
Correspondent
Srs Intl.
1625 K St. NW
Suite 1000
Washington,  DC  20006
Correspondent Contact MICHAEL G FARROW, PH.D.
Regulation Number876.5220
Classification Product Code
KPL  
Date Received02/10/1997
Decision Date 10/31/1997
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
Predetermined Change
Control Plan Authorized		 No
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