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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, processing for frozen blood
Regulation Description Processing system for frozen blood.
Product CodeKSW
Regulation Number 864.9145
Device Class 2


Premarket Reviews
ManufacturerDecision
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 8
  1.  BK000002  Processing Systems for Frozen Blood
  2.  BK030031  Processing Systems for Frozen Blood
  3.  BK030062  Processing Systems for Frozen Blood
  4.  BK040077  Processing Systems for Frozen Blood
  5.  BK050006  Processing Systems for Frozen Blood
  6.  BK060008  Processing Systems for Frozen Blood
  7.  BK840022  Processing Systems for Frozen Blood
  8.  BK840025  Processing Systems for Frozen Blood

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