Mepitel Non Adherent Silicone Dressing
FDA 510(k) K984371 · Molnlycke Health Care, Inc.
510(k) numberK984371
Submission
- Device name
- Mepitel Non Adherent Silicone Dressing
- Applicant
- Molnlycke Health Care, Inc.
Eddystone, PA, US - Received
- December 7, 1998
- Decision date
- March 3, 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 |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | Dermaphylyx, Inc. | 03/25/1999SE |
| 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 |
|---|---|---|
| K130852 | Avance® Foam Abdominal Dressing KitOXJ · Traditional | 04/14/2014SE |
| K130040 | Mepitel AGFRO · Traditional | 02/12/2014SE |
| K123892 | Mepilex Transfer AGFRO · Traditional | 04/05/2013SE |
| K122132 | Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…OMP · Traditional | 01/17/2013SE |
| K102923 | Barrier N95 Particulate RespiratorMSH · Abbreviated | 11/19/2010SE |
| K100029 | Mepilex Border AG DressingFRO · Traditional | 09/15/2010SE |
| K061554 | Mepilex AG Absorbent Silicone-Coated DressingFRO · Traditional | 01/25/2007SE |
| K062138 | Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene…LZA · Special | 10/05/2006SE |
| K051625 | Barrier Surgical DrapesKKX · Special | 07/14/2005SE |
| K050786 | Barrier Surgical GownsFYA · Special | 05/09/2005SE |
Questions and answers
When was Mepitel Non Adherent Silicone Dressing cleared by the FDA?
Mepitel Non Adherent Silicone Dressing (K984371) received a 510(k) decision of Substantially Equivalent on March 3, 1999, 86 days after the submission was received.
What is the product code of K984371?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.