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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gouge, surgical, general & plastic surgery
Regulation Description Manual surgical instrument for general use.
Product CodeGDH
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Break 3
Crack 2
Difficult to insert 2
Unknown (for use when the device problem is not known) 1
Split 1
Detachment of device or device component 1
Flaked 1
Detachment of device component 1
Total Device Problems 12

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