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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enema kit, (for cleaning purpose)
Regulation Description Enema kit.
Product CodeFCE
Regulation Number 876.5210
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Improper or incorrect procedure or method 3
Device, or device fragments remain in patient 1
No Known Device Problem 1
Unintended ejection 1
Use of Device Issue 1
Instruction for use issue 1
Total Device Problems 8

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