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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laryngoscope, non-rigid
Regulation Description Flexible laryngoscope.
Product CodeCAL
Regulation Number 868.5530
Device Class 1


Premarket Reviews
ManufacturerDecision
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device Cleaning Issue 4
Material fragmentation 3
Device or device fragments location unknown 2
Break 1
Image orientation incorrect 1
Poor quality image 1
Tip breakage 1
Component(s), broken 1
No display or display failure 1
Fracture 1
Total Device Problems 16

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