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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device computer assisted hair harvesting system
Regulation Description Stereotaxic instrument.
Definition A computer assisted harvesting system used in identifying and extracting hair follicular units and indicated to assist surgeon in identifying and extracting hair follicular units during hair transplantation.
Product CodeONA
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
RESTORATION ROBOTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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