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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device in situ polymerizing peripheral nerve repair device
Definition An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.
Product CodeSFD
Regulation Number 882.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
TISSIUM SA
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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