← Product Code [NAB](/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB) · K912950 # COMPRESS DRESSING (K912950) _Cal West Trading Co. · NAB · Oct 4, 1991 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K912950 ## Device Facts - **Applicant:** Cal West Trading Co. - **Product Code:** [NAB](/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB.md) - **Decision Date:** Oct 4, 1991 - **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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K912950](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K912950) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K912950