3M Tegasorb Hydrocolloid Dressing
FDA 510(k) K982893 · 3M Company
510(k) numberK982893
Submission
- Device name
- 3M Tegasorb Hydrocolloid Dressing
- Applicant
- 3M Company
St. Paul, MN, US - Received
- August 17, 1998
- Decision date
- October 26, 1998
- 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 |
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| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Tegasorb Hydrocolloid Dressing cleared by the FDA?
3M Tegasorb Hydrocolloid Dressing (K982893) received a 510(k) decision of Substantially Equivalent on October 26, 1998, 70 days after the submission was received.
What is the product code of K982893?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.