# LRR · First Aid Kit With Drug

_ ·  · Class N_

**Canonical URL:** https://fda.innolitics.com/productcode/LRR

## Overview

- **Product Code:** LRR
- **Device Name:** First Aid Kit With Drug
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## 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.

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K964029](/device/K964029.md) | EMERGENCY RELIEF KIT SYSTEM | Baxter Healthcare Corp | Mar 17, 1997 | SEKD |
| [K952561](/device/K952561.md) | WATER JEL BURN KIT | Water-Jel Technologies, Inc. | Jul 14, 1995 | SESE |
| [K940249](/device/K940249.md) | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | Certified Safety Mfg., Inc. | Oct 3, 1994 | SEKD |
| [K941311](/device/K941311.md) | FIRST AID/TRUMA KIT | Certified Safety Mfg., Inc. | Jun 14, 1994 | SESE |
| [K931058](/device/K931058.md) | TICK-ATTACK(TM) KIT | Mind Mechanics, Inc. | Mar 1, 1994 | SESK |
| [K931634](/device/K931634.md) | VARIOUS KITS | Polymint Industrial Co. , Ltd. | Nov 30, 1993 | SEKD |
| [K921762](/device/K921762.md) | SHAWNEE PRODUCTS KIT I | Absentee Shawnee Bandage Group | Jan 6, 1993 | SEKD |
| [K903393](/device/K903393.md) | AUTO FIRST-AID KIT FOR AMERICA | Hisler-Radke, Inc. | Jan 31, 1991 | SESK |
| [K896413](/device/K896413.md) | COMBINATION 6X-MAGNIFIER AND TWEEZERS | James Alexander Corp. | Feb 1, 1990 | SESE |
| [K895767](/device/K895767.md) | ORIGINAL TICK KIT/1ST AID KIT | Tick Kit, Inc. | Dec 22, 1989 | SESD |
| [K891483](/device/K891483.md) | FIRST AID SURVIVAL KIT | Elwyn, Inc. | May 11, 1989 | SESE |
| [K871376](/device/K871376.md) | FIRST AID KIT, VARIOUS SIZES | Fraass Survival Systems, Inc. | Jun 4, 1987 | SESD |
| [K871501](/device/K871501.md) | KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE | Fraass Survival Systems, Inc. | Jun 2, 1987 | SESE |
| [K871457](/device/K871457.md) | FIRST AID KIT, EYE DRESSING | Fraass Survival Systems, Inc. | May 29, 1987 | SESD |
| [K841900](/device/K841900.md) | FIRST RESPONSE EMERG. EYE INJURIES | Reed Products, Inc. | Jul 23, 1984 | SESE |

## Top Applicants

- Fraass Survival Systems, Inc. — 3 clearances
- Certified Safety Mfg., Inc. — 2 clearances
- Absentee Shawnee Bandage Group — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Elwyn, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/LRR](https://fda.innolitics.com/productcode/LRR)

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