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510(k) K152834

Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 by Colonplus Equipments & Speculums, S.L. — Product Code KPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2016
Date Received
September 29, 2015
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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