KOY · Degreaser, Skin, Surgical
General, Plastic Surgery · 21 CFR 878.4730 · Class 1
Overview
| Product Code | KOY |
|---|---|
| Device Name | Degreaser, Skin, Surgical |
| Regulation | 21 CFR 878.4730 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
