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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dynamic rectal control system
Definition Intended to treat fecal incontinence by controlling the size of the rectal lumen.
Product CodePJH
Regulation Number 876.5930
Device Class 2


Premarket Reviews
ManufacturerDecision
PELVALON
  GRANTED 1
PELVALON, INC.
  SUBSTANTIALLY EQUIVALENT 1

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