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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device irrigator, ostomy
Regulation Description Ostomy irrigator.
Product CodeEXD
Regulation Number 876.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2
Foreign material present in device 2
No Known Device Problem 1
Material separation 1
Total Device Problems 6

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