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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hemorrhoid prevention pressure wedge
Definition Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.
Product CodeOOA
Regulation Number 884.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
PLEXUS BIOMEDICAL INC.
  GRANTED 1

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