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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laparoscopic single port access device
Regulation Description Endoscope and accessories.
Definition A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Product CodeOTJ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1

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