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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pressure wedge, perianal, for reduction of cesarean delivery
Definition Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
Product CodePNU
Regulation Number 884.5210
Device Class 2


Premarket Reviews
ManufacturerDecision
STETRIX, INC.
  GRANTED 1

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