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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device irrigator, sinus
Product CodeKAR
Regulation Number 874.4420
Device Class 1


Premarket Reviews
ManufacturerDecision
HEDGEPATH, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2017 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Circuit Failure 1 1
Product Quality Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cellulitis 1 1
Swelling 1 1
Swollen Glands 1 1
Reaction 1 1
Respiratory Tract Infection 1 1
Nasal Obstruction 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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