Innovative Technologies Aliginate/Pectin Wound Dressings
FDA 510(k) K963598 · Innovative Technologies , Ltd.
510(k) numberK963598
Submission
- Device name
- Innovative Technologies Aliginate/Pectin Wound Dressings
- Applicant
- Innovative Technologies , Ltd.
Winsford, Cheshire, GB - Received
- September 9, 1996
- Decision date
- November 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
Other 510(k)s with product code KMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241916 | TearRepair Liquid Skin ProtectantKMF · Traditional | Optmed, Inc. | 09/27/2024SE |
| K182733 | Rochal Bioshield Silicone FilmKMF · Traditional | Rochal Industries, LLC | 06/27/2019SE |
| K171148 | Aleo BME Liquid BandageKMF · Traditional | Aleo Bme, Inc. | 01/12/2018SE |
| K153571 | Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional | 3M Healthcare | 08/23/2016SE |
| K160684 | Atteris No-Sting Skin ProtectantKMF · Traditional | Rochal Industries, LLC | 07/26/2016SE |
| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional | Kericure, Inc. | 08/07/2014SE |
| K133443 | Marathon No Sting Liquid Skin ProtectantKMF · Traditional | Advanced Medical Solutions (Plymouth), Ltd. | 07/10/2014SE |
| K120059 | Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 05/17/2012SE |
| K092712 | Skin Barrier FilmKMF · Traditional | Lodestar Products, Inc. | 02/23/2010SE |
| K083087 | EcocelKMF · Traditional | Polichem S.A | 08/07/2009SE |
More from Polichem S.A
| 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 |
| K971126 | Hydrocolloid Wound DressingsFRO · Traditional | 06/24/1997SE |
Questions and answers
When was Innovative Technologies Aliginate/Pectin Wound Dressings cleared by the FDA?
Innovative Technologies Aliginate/Pectin Wound Dressings (K963598) received a 510(k) decision of Substantially Equivalent on November 27, 1996, 79 days after the submission was received.
What is the product code of K963598?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.