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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device cream, nasal, topical, mechanical allergen particle barrier
Regulation Description Medical recirculating air cleaner.
Definition THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
Product CodeNUP
Regulation Number 880.5045
Device Class 2


Premarket Reviews
ManufacturerDecision
NASALEZE INTERNATIONAL LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Necrosis 1 1
Injury 1 1

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