BTF Thin Film Wound Dressing
FDA 510(k) K982939 · Bioderm, Inc.
510(k) numberK982939
Submission
- Device name
- BTF Thin Film Wound Dressing
- Applicant
- Bioderm, Inc.
St. Petersburg, FL, US - Received
- August 21, 1998
- Decision date
- October 13, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGP – Dressing, Wound And Burn, Occlusive
- Device class
- Unclassified
Other 510(k)s with product code MGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012997 | Collatek FoamMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K012995 | Collatek SheetMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K001508 | Laserskin DressingMGP · Traditional | Fidia Advanced Biopolymers Srl | 07/25/2001SE |
| K990079 | Fastseal Chest Wound DressingMGP · Traditional | Greenfield Medical Technologies, Inc. | 12/23/1999SE |
| K991214 | Simplicare Transparent Wound DressingMGP · Traditional | Hollister, Inc. | 10/14/1999SE |
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | Dermaphylyx, Inc. | 09/14/1999SE |
| K992005 | Giltech Plus Transparent DressingMGP · Traditional | Giltech Plus, Inc. | 09/03/1999SE |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | Dermaphylyx, Inc. | 05/27/1999SN |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | Dermaphylyx, Inc. | 03/25/1999SE |
| K984371 | Mepitel Non Adherent Silicone DressingMGP · Traditional | Molnlycke Health Care, Inc. | 03/03/1999SE |
More from Molnlycke Health Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990955 | Modification Of:Bioderm Foam Wound DressingKMF · Traditional | 05/18/1999SE |
| K982778 | Bioderm Foam Wound DressingKMF · Traditional | 10/21/1998SE |
| 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 BTF Thin Film Wound Dressing cleared by the FDA?
BTF Thin Film Wound Dressing (K982939) received a 510(k) decision of Substantially Equivalent on October 13, 1998, 53 days after the submission was received.
What is the product code of K982939?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.