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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, insulin bolus
Definition The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Product CodeOPP
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
CEQUR SA
  SUBSTANTIALLY EQUIVALENT 1

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