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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture, intravaginal, assisted reproduction
Regulation Description Intravaginal culture system.
Definition Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.
Product CodeOYO
Regulation Number 884.6165
Device Class 2


Premarket Reviews
ManufacturerDecision
INVO BIOSCIENCE
  SUBSTANTIALLY EQUIVALENT 1

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