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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device colonic irrigation system
Product CodeKPL
Regulation Number 876.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
CLEARWATER PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
COLONIC PLUS
  SUBSTANTIALLY EQUIVALENT - KIT 1
COLONPLUS EQUIPMENTS & SPECULUMS, S.L.
  SUBSTANTIALLY EQUIVALENT 1
GNALI BOCIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
QUALITY MEDICAL SUPPLY, INC
  SUBSTANTIALLY EQUIVALENT 1
TRANSCENDENCIAS COMERCIALES SL TRANSCOM
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Issue 1 1
Missing Value Reason 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 1 1
Injury 1 1
Bowel Perforation 1 1
Patient Problem/Medical Problem 1 1

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