Dukal Transparent Wound Dressing
FDA 510(k) K955476 · Dukal Corp.
510(k) numberK955476
Submission
- Device name
- Dukal Transparent Wound Dressing
- Applicant
- Dukal Corp.
Palm Harobor, FL, US - Received
- November 30, 1995
- Decision date
- January 18, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- MGP – Dressing, Wound And Burn, Occlusive
- Device class
- Unclassified
Other 510(k)s with product code MGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012997 | Collatek FoamMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K012995 | Collatek SheetMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K001508 | Laserskin DressingMGP · Traditional | Fidia Advanced Biopolymers Srl | 07/25/2001SE |
| K990079 | Fastseal Chest Wound DressingMGP · Traditional | Greenfield Medical Technologies, Inc. | 12/23/1999SE |
| K991214 | Simplicare Transparent Wound DressingMGP · Traditional | Hollister, Inc. | 10/14/1999SE |
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | Dermaphylyx, Inc. | 09/14/1999SE |
| K992005 | Giltech Plus Transparent DressingMGP · Traditional | Giltech Plus, Inc. | 09/03/1999SE |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | Dermaphylyx, Inc. | 05/27/1999SN |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | Dermaphylyx, Inc. | 03/25/1999SE |
| K984371 | Mepitel Non Adherent Silicone DressingMGP · Traditional | Molnlycke Health Care, Inc. | 03/03/1999SE |
More from Molnlycke Health Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252823 | Dukal Crepe Paper Sterilization WrapFRG · Traditional | 05/28/2026SE |
| K233262 | Dukal SMS Sterilization WrapFRG · Traditional | 03/22/2024SE |
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective GownQPC · Traditional | 03/30/2022SE |
| K210321 | Dukal Corporation Level 1 Pediatric Face MaskOXZ · Traditional | 03/29/2022SE |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown…FYA · Traditional | 03/18/2022SE |
| K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3…FXX · Traditional | 02/16/2021SE |
| K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2…FXX · Traditional | 02/05/2021SE |
| K113689 | Dukal Lubricating JellyKMJ · Traditional | 05/04/2012SE |
| K083320 | Dukal Surgical Drape; Fenestrated Dukal Surgical DrapeKKX · Traditional | 03/06/2009SE |
| K070692 | Dukal N95PARTICULATE Respirator/Surgical Face MaskMSH · Traditional | 05/30/2007SE |
Questions and answers
When was Dukal Transparent Wound Dressing cleared by the FDA?
Dukal Transparent Wound Dressing (K955476) received a 510(k) decision of Substantially Equivalent for Some Indications on January 18, 1996, 49 days after the submission was received.
What is the product code of K955476?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.