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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device parathyroid autofluorescence imaging device
Regulation Description Autofluorescence detection device for general surgery and dermatological use.
Definition An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
Product CodeQDG
Regulation Number 878.4550
Device Class 2


Premarket Reviews
ManufacturerDecision
DENDRITE IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLUOPTICS SAS
  SUBSTANTIALLY EQUIVALENT 1
FLUOPTICS SAS (A GETINGE GROUP COMPANY)
  SUBSTANTIALLY EQUIVALENT 1
FLUOPTICS SAS (A GETINGE GROUP COMPANY}
  SUBSTANTIALLY EQUIVALENT 1

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