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510(k) K131852

HC-1 AND HC-1 CLASSIC by Transcendencias Comerciales SL Transcom — Product Code KPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2014
Date Received
June 21, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colonic Irrigation System
Device Class
Class II
Regulation Number
876.5220
Review Panel
GU
Submission Type

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