Dressing, Burn, 24 by 36 Inches
FDA 510(k) K870239 · Fraass Survival Systems, Inc.
510(k) numberK870239
Submission
- Device name
- Dressing, Burn, 24 by 36 Inches
- Applicant
- Fraass Survival Systems, Inc.
Bronx, NY, US - Received
- January 21, 1987
- Decision date
- February 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAD – Dressing, Wound, Occlusive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 09/10/2026SE |
| K102403 | Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional | Sam Medical Products | 03/03/2011SE |
| K091133 | Aplion Topical Care SystemNAD · Traditional | Aplion Medical,Llc | 05/20/2009SE |
| K072560 | Envela (Hydrohesive Occlusive Dressing)NAD · Traditional | Teikoku Pharma USA, Inc. | 06/17/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | Tri-State Hospital Supply Corp. | 04/23/2008SE |
| K060046 | DermastreamNAD · Traditional | Enzysurge , Ltd. | 02/27/2006SE |
| K043063 | Oxyband Wound DressingNAD · Traditional | Oxyband Technologies, Inc. | 03/24/2005SE |
| K020781 | Wet ChamberNAD · Traditional | Kinetic Concepts, Inc. | 05/06/2002SE |
| K990530 | Kerlix MD Antimicrobial Gauze DressingNAD · Traditional | The Kendall Company, L.P. | 01/31/2000SE |
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | Hospital Specialty Co. | 04/12/1999SE |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K912022 | Frastec Drynet, Bridal Veil, Various SizesNAD · Traditional | 08/02/1991SE |
| K871458 | Survival Kit, Individual, Trop, Tactical Air CrewKDD · Traditional | 07/09/1987SE |
| K871437 | Survival Kit, IndividualLRO · Traditional | 07/09/1987SE |
| K871434 | Medical Packet, Individual Survival Kit, Airman'sLRO · Traditional | 07/09/1987SE |
| K871917 | Frastec Dry Gauze BandageEFQ · Traditional | 06/16/1987SN |
| K871916 | Frastec Dry Burn DressingEFQ · Traditional | 06/16/1987SN |
| K871376 | First Aid Kit, Various SizesLRR · Traditional | 06/04/1987SESD |
| K871501 | Kit, First Aid, General Purpose, Rigid CaseLRR · Traditional | 06/02/1987SE |
| K871457 | First Aid Kit, Eye DressingLRR · Traditional | 05/29/1987SESD |
| K871438 | Bandage, Muslin, Compressed, Camouflaged 37X37X52EFQ · Traditional | 05/06/1987SE |
Questions and answers
When was Dressing, Burn, 24 by 36 Inches cleared by the FDA?
Dressing, Burn, 24 by 36 Inches (K870239) received a 510(k) decision of Substantially Equivalent on February 6, 1987, 16 days after the submission was received.
What is the product code of K870239?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.