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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device detectors and removers, lice, (including combs)
Product CodeLJL
Regulation Number 880.5960
Device Class 1


Premarket Reviews
ManufacturerDecision
LARADA SCIENCES
  SUBSTANTIALLY EQUIVALENT 2
MEDTECH PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
PIEDMONT PHARMACEUTICALS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hair Loss 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1
Nausea 1 1
Pain 1 1
Scar Tissue 1 1
Seizures 1 1
Caustic/Chemical Burns 1 1
Localized Skin Lesion 1 1
Skin Infection 1 1

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