Innovative Technologies Transparent Film and Intelligent Film Wound Dressing
FDA 510(k) K981753 · Innovative Technologies , Ltd.
510(k) numberK981753
Submission
- Device name
- Innovative Technologies Transparent Film and Intelligent Film Wound Dressing
- Applicant
- Innovative Technologies , Ltd.
Winsford, Cheshire, GB - Received
- May 18, 1998
- Decision date
- June 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K983303 | Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound DressingsMGP · Traditional | 12/09/1998SE |
| K982234 | Al-Gen Calcium Alginate DressingKMF · Traditional | 09/08/1998SE |
| K982638 | 3M Tegagen Hi Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S…QSY · Traditional | 08/21/1998SE |
| K980989 | 3M Tegagen Hi Alginate Dressing & 3M Tegagen HG Alginate DressingKMF · Traditional | 05/27/1998SE |
| K980097 | Flexigel-G Hydrogel Wound DressingMGQ · Traditional | 03/04/1998SE |
| K973855 | It Hydrocolloid with ZincFRO · Traditional | 12/01/1997SN |
| K973312 | Transparent Film Dressing, Intelligent Film DressingMGP · Traditional | 10/22/1997SE |
| K973283 | Alginate/Zinc Wound DressingKMF · Traditional | 10/21/1997SN |
| K971126 | Hydrocolloid Wound DressingsFRO · Traditional | 06/24/1997SE |
| K963598 | Innovative Technologies Aliginate/Pectin Wound DressingsKMF · Traditional | 11/27/1996SE |
Questions and answers
When was Innovative Technologies Transparent Film and Intelligent Film Wound Dressing cleared by the FDA?
Innovative Technologies Transparent Film and Intelligent Film Wound Dressing (K981753) received a 510(k) decision of Substantially Equivalent on June 30, 1998, 43 days after the submission was received.
What is the product code of K981753?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.