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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope channel accessory
Regulation Description Endoscope and accessories.
Definition To give the endoscope channel additional or improved functionality.
Product CodeODC
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGEION CORP.
  SUBSTANTIALLY EQUIVALENT 1
APOLLO CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
LSI SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device contamination with blood or blood product 1
Detachment of device or device component 1
Total Device Problems 2

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