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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bedding, disposable, medical
Regulation Description Medical disposable bedding.
Product CodeKME
Regulation Number 880.6060
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 3
TECHTRADE LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Tears, rips, holes in device, device material 2
Total Device Problems 2

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