Certiburn Burn/Trauma Face Dressing /Towel Dressing
FDA 510(k) K940249 · Certified Safety Mfg., Inc.
510(k) numberK940249
Submission
- Device name
- Certiburn Burn/Trauma Face Dressing /Towel Dressing
- Applicant
- Certified Safety Mfg., Inc.
Kansas City, MO, US - Received
- January 19, 1994
- Decision date
- October 3, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K903393 | Auto First-Aid Kit for AmericaLRR · Traditional | Hisler-Radke, Inc. | 01/31/1991SESK |
| 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 |
More from Elwyn, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960587 | Cprotector 2000CBP · Traditional | 07/21/1997SE |
| K960615 | Gauze CompressEFQ · Traditional | 11/25/1996SN |
| K960624 | Certi Cool Instant Cold CompressIMD · Traditional | 05/06/1996SN |
| K953102 | Bloodborne Pathogen KitFXX · Traditional | 12/11/1995SE |
| K946338 | Certiburn Burn/Trauma Face Dressing, Towel DressingMGP · Traditional | 03/29/1995SE |
| K945004 | 2, 3 & 4 Bandadge CompressEFQ · Traditional | 03/22/1995SE |
| K945002 | 1X6YD, 2X6YD, 4X6YD Roll BandageEFQ · Traditional | 03/22/1995SE |
| K941311 | First Aid/Truma KitLRR · Traditional | 06/14/1994SE |
| K940358 | X-Large Multi-Function Trauma DressingEFQ · Traditional | 03/23/1994SE |
| K940336 | Certi Heat Instant Heat CompressIMD · Traditional | 03/07/1994SE |
Questions and answers
When was Certiburn Burn/Trauma Face Dressing /Towel Dressing cleared by the FDA?
Certiburn Burn/Trauma Face Dressing /Towel Dressing (K940249) received a 510(k) decision of Unknown on October 3, 1994, 257 days after the submission was received.
What is the product code of K940249?
The FDA product code is LRR – First Aid Kit With Drug, a Not classified device.