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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, surgical, sonic and accessory/attachment
Regulation Description Sonic surgical instrument and accessories/attachments.
Product CodeJDX
Regulation Number 888.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SATELEC
  SUBSTANTIALLY EQUIVALENT 1
SRA DEVELOPMENTS, LTD.
  SUBSTANTIALLY EQUIVALENT 1

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