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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anal fistula closure device
Definition An anal fistula closure device is a surgical implant for anal fistula repair and is intended for closure of the anal fistula. The device may be manually applied or delivered with a delivery device.
Product CodeQML
Regulation Number 878.4835
Device Class 2


Premarket Reviews
ManufacturerDecision
SIGNUM SURGICAL LIMITED
  GRANTED 1

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