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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps, biopsy, bronchoscope (non-rigid)
Regulation Description Bronchoscope (flexible or rigid) and accessories.
Product CodeBWH
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Detachment of device component 1
Cable break 1
Mechanical issue 1
Total Device Problems 3

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