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510(k) K180800

Colonic Plus Regular, Small, and Straight Shape Hydrokit by Colonic Plus — Product Code KPL

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 1, 2018
Date Received
March 27, 2018
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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