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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessory, assisted reproduction
Regulation Description Assisted reproduction accessories.
Product CodeMQG
Regulation Number 884.6120
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
GENX INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
MID-ATLANTIC DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINITUBE OF AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
NONE
  SUBSTANTIALLY EQUIVALENT 2

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