It Hydrocolloid with Zinc
FDA 510(k) K973855 · Innovative Technologies , Ltd.
510(k) numberK973855
Submission
- Device name
- It Hydrocolloid with Zinc
- Applicant
- Innovative Technologies , Ltd.
Winsford, Cheshire, GB - Received
- October 9, 1997
- Decision date
- December 1, 1997
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
| 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 It Hydrocolloid with Zinc cleared by the FDA?
It Hydrocolloid with Zinc (K973855) received a 510(k) decision of Substantially Equivalent for Some Indications on December 1, 1997, 53 days after the submission was received.
What is the product code of K973855?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.