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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pneumoperitoneum needle
Regulation Description Endoscope and accessories.
Definition For establishment of a pneumoperitoneum in abdomen.
Product CodeFHO
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
HENKE SASS WOLF
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

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