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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device at home intravaginal insemination system
Definition To deliver semen to the vaginal canal for insemination.
Product CodeQYZ
Regulation Number 884.6110
Device Class 2


Premarket Reviews
ManufacturerDecision
HANNAH LIFE TECHNOLOGIES PTE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOSIE BABY
  SUBSTANTIALLY EQUIVALENT 1
PHERDAL FERTILITY SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

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