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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cover, shoe, operating-room
Regulation Description Surgical apparel.
Product CodeFXP
Regulation Number 878.4040
Device Class 1


Premarket Reviews
ManufacturerDecision
A PLUS INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1

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