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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cranial measurement software
Regulation Description Manual surgical instrument for general use.
Definition Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods.
Product CodeQQO
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
PEDIAMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1

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