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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cream, nasal, topical, mechanical allergen particle barrier
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
ALTAMIRA THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HAYMAX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HI-TECH PHARMACAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NASALEZE INTERNATIONAL LTD
  SUBSTANTIALLY EQUIVALENT 2
RHINIX APS
  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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