FTN · Plastic Surgery And Accessories Kit
General, Plastic Surgery · 21 CFR 878.3925 · Class 1
Overview
| Product Code | FTN |
|---|---|
| Device Name | Plastic Surgery And Accessories Kit |
| Regulation | 21 CFR 878.3925 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
