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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated cryopreservation storage system
Regulation Description Assisted reproduction accessories.
Definition To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.
Product CodeQUJ
Regulation Number 884.6120
Device Class 2


Premarket Reviews
ManufacturerDecision
TMRW LIFE SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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