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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device strip, adhesive, closure, skin
Product CodeFPX
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 6
DUKAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
GAINOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Human factors issue 9
No Known Device Problem 8
Human-Device Interface Issue 2
Total Device Problems 19

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