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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device semi-automated autologous skin graft harvesting and application device
Definition A semi- automated autologous skin graft harvesting and application device is a handheld electromechanical surgical instrument that extracts autologous skin graft tissue from a healthy donor skin site and deposits it to a recipient site. The device extraction and deposition functions are automated and are activated by the user. The device is not intended for treatment of third degree burns.
Product CodeQYK
Regulation Number 878.4795
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDLINE INDUSTRIES, INC.
  GRANTED 1

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