← Product Code [EYF](/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF) · K832908

# COMFEEL PROTECTIVE RINGS (K832908)

_Coloplast A/S · EYF · Dec 12, 1983 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K832908

## Device Facts

- **Applicant:** Coloplast A/S
- **Product Code:** [EYF](/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF.md)
- **Decision Date:** Dec 12, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4014
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K832908](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EYF/K832908)

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