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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 K131852
Device Name HC-1 AND HC-1 CLASSIC
Applicant
Transcendencias Comerciales SL Transcom
C/Zubiberri 31- Planta Baja Local 1
San Sebastian, Guipuzcoa,  ES 20018
Applicant Contact RAMON ECHEVARRIA
Correspondent
Transcendencias Comerciales SL Transcom
C/Zubiberri 31- Planta Baja Local 1
San Sebastian, Guipuzcoa,  ES 20018
Correspondent Contact RAMON ECHEVARRIA
Regulation Number876.5220
Classification Product Code
KPL  
Date Received06/21/2013
Decision Date 04/17/2014
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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