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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device media, culture, ex vivo, tissue and cell
Product CodeNDS
Regulation Number 876.5885
Device Class 2


Premarket Reviews
ManufacturerDecision
ENERGY DELIVERY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Life Technologies Corporation II Nov-06-2019
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