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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device media and components, synthetic cell and tissue culture
Regulation Description Synthetic cell and tissue culture media and components.
Product CodeKIT
Regulation Number 864.2220
Device Class 1


Premarket Reviews
ManufacturerDecision
COLLAGEN
  SUBSTANTIALLY EQUIVALENT 1
OSTEOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
SIGMA
  SUBSTANTIALLY EQUIVALENT 2

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