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

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device mesh, surgical, non-absorbable, facial implants for plastic surgery
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists in facial plastic surgery.
Physical State A plastic polymer mesh; either square, rectangular, or round.
Technical Method A non-absorbable mesh that reinforces soft tissue.
Target Area Face
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOWR
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-