ESF · Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
General, Plastic Surgery · 21 CFR 878.3500 · Class 2
Overview
| Product Code | ESF |
|---|---|
| Device Name | Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent |
| Regulation | 21 CFR 878.3500 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891247 | BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC | Siemens Hearing Instruments, Inc. | Mar 29, 1989 | SESE |
| K813224 | CERAVITAL CERAMIC EAR CANAL WALL PROSTH | Xomed, Inc. | Apr 21, 1982 | SESE |
Top Applicants
- Xomed, Inc. — 1 clearance
- Siemens Hearing Instruments, Inc. — 1 clearance
