Auto First-Aid Kit for America
FDA 510(k) K903393 · Hisler-Radke, Inc.
510(k) numberK903393
Submission
- Device name
- Auto First-Aid Kit for America
- Applicant
- Hisler-Radke, Inc.
Las Vegas, NV, US - Received
- July 27, 1990
- Decision date
- January 31, 1991
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRR – First Aid Kit With Drug
- Device class
- Not classified
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…
Other 510(k)s with product code LRR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964029 | Emergency Relief Kit SystemLRR · Traditional | Baxter Healthcare Corp | 03/17/1997SEKD |
| K952561 | Water Jel Burn KitLRR · Traditional | Water-Jel Technologies, Inc. | 07/14/1995SE |
| K940249 | Certiburn Burn/Trauma Face Dressing /Towel DressingLRR · Traditional | Certified Safety Mfg., Inc. | 10/03/1994SEKD |
| K941311 | First Aid/Truma KitLRR · Traditional | Certified Safety Mfg., Inc. | 06/14/1994SE |
| K931058 | Tick-Attack(Tm) KitLRR · Traditional | Mind Mechanics, Inc. | 03/01/1994SESK |
| K931634 | Various KitsLRR · Traditional | Polymint Industrial Co. , Ltd. | 11/30/1993SEKD |
| K921762 | Shawnee Products Kit ILRR · Traditional | Absentee Shawnee Bandage Group | 01/06/1993SEKD |
| K896413 | Combination 6X-MAGNIFIER and TweezersLRR · Traditional | James Alexander Corp. | 02/01/1990SE |
| K895767 | Original Tick KIT/1ST Aid KitLRR · Traditional | Tick Kit, Inc. | 12/22/1989SESD |
| K891483 | First Aid Survival KitLRR · Traditional | Elwyn, Inc. | 05/11/1989SE |
Questions and answers
When was Auto First-Aid Kit for America cleared by the FDA?
Auto First-Aid Kit for America (K903393) received a 510(k) decision of Unknown on January 31, 1991, 188 days after the submission was received.
What is the product code of K903393?
The FDA product code is LRR – First Aid Kit With Drug, a Not classified device.