← Product Code [LRR](/productcode/LRR) · K841900

# FIRST RESPONSE EMERG. EYE INJURIES (K841900)

_Reed Products, Inc. · LRR · Jul 23, 1984 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K841900

## Device Facts

- **Applicant:** Reed Products, Inc.
- **Product Code:** [LRR](/productcode/LRR.md)
- **Decision Date:** Jul 23, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class N
- **Review Panel:** SU

## Regulatory Identification

Note:  In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well.  www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

---

**Source:** [https://fda.innolitics.com/device/K841900](https://fda.innolitics.com/device/K841900)

**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