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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, eyelid spacer/graft, polymer
Definition For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.
Product CodeQWU
Regulation Number 886.3130
Device Class 2


Premarket Reviews
ManufacturerDecision
CORNEAT VISION LTD.
  SUBSTANTIALLY EQUIVALENT 1

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