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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device high intensity focused ultrasound system for peripheral neural tissue ablation
Definition A high intensity focused ultrasound system for peripheral neural tissue ablation is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling.
Product CodeSGN
Regulation Number 882.4420
Device Class 2


Premarket Reviews
ManufacturerDecision
FUSMOBILE, INC.
  GRANTED 1

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