Product Classification

• Device: prosthesis, nose, internal
• Regulation Description: Nose prosthesis.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: FZE
• Premarket Review: Plastic and Reconstructive Surgery Devices (DHT4B); Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 878.3680
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 8-179 ASTM F754-08 (Reapproved 2015)
  Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
• 8-628 ASTM F754-24
  Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

Third Party Review

Not Third Party Eligible