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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, nasal
Regulation Description Nasal dilator.
Product CodeLWF
Regulation Number 874.3900
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 4
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VENTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 38
Failure to obtain samples 10
Device operates differently than expected 4
Inadequate storage 1
Invalid sensing 1
Total Device Problems 54

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