← Product Code EWD · K821187

# MEDCO CUSTOM EAR PROTECTOR MOLD KIT (K821187)

_Santa Barbara Medco, Inc. · EWD · May 27, 1982 · EN · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K821187

## Device Facts

- **Applicant:** Santa Barbara Medco, Inc.
- **Product Code:** EWD
- **Decision Date:** May 27, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** EN

---

**Source:** [https://fda.innolitics.com/device/K821187](https://fda.innolitics.com/device/K821187)

**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:** Innolitics at https://innolitics.com