Bioderm Foam Wound Dressing
FDA 510(k) K982778 · Bioderm, Inc.
510(k) numberK982778
Submission
- Device name
- Bioderm Foam Wound Dressing
- Applicant
- Bioderm, Inc.
Wheaton, IL, US - Received
- August 7, 1998
- Decision date
- October 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
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|---|---|---|---|
| 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 |
|---|---|---|
| K990955 | Modification Of:Bioderm Foam Wound DressingKMF · Traditional | 05/18/1999SE |
| K982939 | BTF Thin Film Wound DressingMGP · Traditional | 10/13/1998SE |
| K980451 | Bioderm Calcium Alginate DressingKMF · Traditional | 04/09/1998SN |
| K973429 | Bioderm Foam Wound DressingKMF · Traditional | 12/01/1997SN |
| K963950 | Bioderm Eid Male External Incontinence DeviceEXI · Traditional | 01/10/1997SE |
| K963602 | Bioderm PVP Foam Wound DressingKMF · Traditional | 10/30/1996SE |
| K951166 | Bioderm Medical Hydrogel Island DressingNAE · Traditional | 06/21/1995SE |
| K951842 | Bioderm Medical Transparent Film DressingMGP · Traditional | 06/12/1995SE |
| K950685 | Bioderm Medical Hydrocolloid Wound DressingKMF · Traditional | 06/09/1995SE |
| K950619 | Bioderm Medical Foam Wound DressingKMF · Traditional | 04/25/1995SE |
Questions and answers
When was Bioderm Foam Wound Dressing cleared by the FDA?
Bioderm Foam Wound Dressing (K982778) received a 510(k) decision of Substantially Equivalent on October 21, 1998, 75 days after the submission was received.
What is the product code of K982778?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.