Mwi 400 Wound Dressing
FDA 510(k) K874470 · Med-West, Inc.
510(k) numberK874470
Submission
- Device name
- Mwi 400 Wound Dressing
- Applicant
- Med-West, Inc.
Salt Lake City, UT, US - Received
- November 2, 1987
- Decision date
- December 18, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K880877 | Contrast Injection DeviceDXT · Traditional | 05/31/1988SE |
| K880398 | Power Toilet ElevatorINO · Traditional | 03/17/1988SE |
| K872724 | Sheath/DilatorsDRE · Traditional | 09/15/1987SE |
| K854612 | Acute Hemodialysis Tray, CAT.#09-9540-7LFK · Traditional | 01/03/1986SESD |
| K852162 | Mni 400 Injection CapsLFJ · Traditional | 06/12/1985SE |
| K842342 | Mwi 888 & 666 Double Lumen Subclavian · Traditional | 06/14/1984SESP |
| K832124 | CPC, Couble Lumen Cardioplegia-Air AspiDWF · Traditional | 08/12/1983SE |
| K831828 | Teflon Femoral Catheter Mwi 100,10 &LFK · Traditional | 07/07/1983SE |
| K831440 | Single Needle Subclavian Vein MWI250/260FIQ · Traditional | 06/03/1983SE |
| K831401 | Single Needle Subclavian Vein AccessFIQ · Traditional | 06/03/1983SE |
Questions and answers
When was Mwi 400 Wound Dressing cleared by the FDA?
Mwi 400 Wound Dressing (K874470) received a 510(k) decision of Substantially Equivalent for Some Indications on December 18, 1987, 46 days after the submission was received.
What is the product code of K874470?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.