← Product Code LRR · K941311

# FIRST AID/TRUMA KIT (K941311)

_Certified Safety Mfg., Inc. · LRR · Jun 14, 1994 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K941311

## Device Facts

- **Applicant:** Certified Safety Mfg., Inc.
- **Product Code:** LRR
- **Decision Date:** Jun 14, 1994
- **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.

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**Source:** [https://fda.innolitics.com/device/K941311](https://fda.innolitics.com/device/K941311)

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