• 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 Back To Search Results
Device mesh, surgical, collagen, staple line reinforcement
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Product CodeOXE
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS SURGICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1

-
-