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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device labware, assisted reproduction
Product CodeMQK
Regulation Number 884.6160
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
BONRAYBIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CYTOSWIM LTD
  SUBSTANTIALLY EQUIVALENT 1
HERTART APS
  SUBSTANTIALLY EQUIVALENT 1
ORIGIO A/S
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE A/S
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II May-17-2022
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