Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4730](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4730) → KOY — Degreaser, Skin, Surgical

# KOY · Degreaser, Skin, Surgical

_General, Plastic Surgery · 21 CFR 878.4730 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOY

## Overview

- **Product Code:** KOY
- **Device Name:** Degreaser, Skin, Surgical
- **Regulation:** [21 CFR 878.4730](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4730)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOY](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOY)

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