Hydrocolloid Wound Dressings
FDA 510(k) K971126 · Innovative Technologies , Ltd.
510(k) numberK971126
Submission
- Device name
- Hydrocolloid Wound Dressings
- Applicant
- Innovative Technologies , Ltd.
Winsford, Cheshire, GB - Received
- March 27, 1997
- Decision date
- June 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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More from Solventum Germany GmbH
| 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 |
| K981753 | Innovative Technologies Transparent Film and Intelligent Film Wound DressingMGP · Traditional | 06/30/1998SE |
| 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 |
| K963598 | Innovative Technologies Aliginate/Pectin Wound DressingsKMF · Traditional | 11/27/1996SE |
Questions and answers
When was Hydrocolloid Wound Dressings cleared by the FDA?
Hydrocolloid Wound Dressings (K971126) received a 510(k) decision of Substantially Equivalent on June 24, 1997, 89 days after the submission was received.
What is the product code of K971126?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.