• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device pressure wedge, perianal, for reduction of cesarean delivery
Regulation Description Pressure wedge for the 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

-
-