Dermaphylyx Film Wound Dressing and Healian Film Wound Dressing
FDA 510(k) K990875 · Dermaphylyx, Inc.
510(k) numberK990875
Submission
- Device name
- Dermaphylyx Film Wound Dressing and Healian Film Wound Dressing
- Applicant
- Dermaphylyx, Inc.
Arvada, CO, US - Received
- March 16, 1999
- Decision date
- May 27, 1999
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
| 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 |
| 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 |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | 03/25/1999SE |
Questions and answers
When was Dermaphylyx Film Wound Dressing and Healian Film Wound Dressing cleared by the FDA?
Dermaphylyx Film Wound Dressing and Healian Film Wound Dressing (K990875) received a 510(k) decision of Substantially Equivalent for Some Indications on May 27, 1999, 72 days after the submission was received.
What is the product code of K990875?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.