Procel Burn Cover/Procel Burn Treatment Cover
FDA 510(k) K943280 · W.L. Gore & Company, GmbH
510(k) numberK943280
Submission
- Device name
- Procel Burn Cover/Procel Burn Treatment Cover
- Applicant
- W.L. Gore & Company, GmbH
Putzbrunn, DE - Received
- July 7, 1994
- Decision date
- August 18, 1994
- 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 |
| 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 |
Questions and answers
When was Procel Burn Cover/Procel Burn Treatment Cover cleared by the FDA?
Procel Burn Cover/Procel Burn Treatment Cover (K943280) received a 510(k) decision of Substantially Equivalent for Some Indications on August 18, 1994, 42 days after the submission was received.
What is the product code of K943280?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.