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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, suction, uterine
Product CodeHGH
Regulation Number 884.5070
Device Class 2


Premarket Reviews
ManufacturerDecision
CHONGQUIN JINSHAN SCIENCE & TECHNOLOGY (GROUP) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WOMANCARE GLOBAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 1 1
Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 1 1
Pain 1 1
Perforation 1 1
Septic Shock 1 1
Tissue Damage 1 1
Bowel Perforation 1 1

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