Dermaphylyx Skin Protectors, Protect It Skin Protectors
FDA 510(k) K992302 · Dermaphylyx, Inc.
510(k) numberK992302
Submission
- Device name
- Dermaphylyx Skin Protectors, Protect It Skin Protectors
- Applicant
- Dermaphylyx, Inc.
Arvada, CO, US - Received
- July 8, 1999
- Decision date
- September 14, 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 |
| 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 |
| 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 |
|---|---|---|
| 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 |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | 03/25/1999SE |
Questions and answers
When was Dermaphylyx Skin Protectors, Protect It Skin Protectors cleared by the FDA?
Dermaphylyx Skin Protectors, Protect It Skin Protectors (K992302) received a 510(k) decision of Substantially Equivalent on September 14, 1999, 68 days after the submission was received.
What is the product code of K992302?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.