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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
AT MEDICAL UAB
  SUBSTANTIALLY EQUIVALENT 2
ORIGIO, INC
  SUBSTANTIALLY EQUIVALENT 1
UNISENSE FERTILITECH A/S
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE A/S
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Apr-19-2018
2 Cook Inc. II Apr-13-2018

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