Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing, Healiafoam Wound Dressing
FDA 510(k) K990438 · Dermaphylyx, Inc.
510(k) numberK990438
Submission
- Device name
- Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing, Healiafoam Wound Dressing
- Applicant
- Dermaphylyx, Inc.
Arvada, CO, US - Received
- February 11, 1999
- Decision date
- March 25, 1999
- 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 |
| K984371 | Mepitel Non Adherent Silicone DressingMGP · Traditional | Molnlycke Health Care, Inc. | 03/03/1999SE |
| K983303 | Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound DressingsMGP · Traditional | Innovative Technologies , Ltd. | 12/09/1998SE |
More from Innovative Technologies , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | 09/14/1999SE |
| K991920 | Dermaphylyx Hydrophilic Foam Wound DressingKMF · Traditional | 08/12/1999SE |
| K991933 | Dermaphylyx Foam Island DressingKMF · Traditional | 07/30/1999SE |
| K991609 | Dermaphylyx Super Absorbent Fiber DressingKMF · Traditional | 07/20/1999SE |
| K991608 | Dermaphylyx Calcium Alginate Wound DressingKMF · Traditional | 07/20/1999SE |
| K991061 | Dermaphylyx Calcium Alginate Wound DressingNAE · Traditional | 06/28/1999SE |
| K990891 | Dermaphylyx Hydrocolloid Wound Dressing, Healian Hydrocolloid Wound DressingFRO · Traditional | 05/27/1999SN |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | 05/27/1999SN |
Questions and answers
When was Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing, Healiafoam Wound Dressing cleared by the FDA?
Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing, Healiafoam Wound Dressing (K990438) received a 510(k) decision of Substantially Equivalent on March 25, 1999, 42 days after the submission was received.
What is the product code of K990438?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.