NOK · Material, External Aesthetic Restoration, No Adhesive
General, Plastic Surgery · 21 CFR 878.3800 · Class 1
Overview
| Product Code | NOK |
|---|---|
| Device Name | Material, External Aesthetic Restoration, No Adhesive |
| Regulation | 21 CFR 878.3800 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
| GMP Exempt | Yes |
Identification
An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.
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 the limitations in § 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
