Mepilex Border AG Dressing
FDA 510(k) K100029 · Molnlycke Health Care
510(k) numberK100029
Submission
- Device name
- Mepilex Border AG Dressing
- Applicant
- Molnlycke Health Care
Norcross, GA, US - Received
- January 6, 2010
- Decision date
- September 15, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
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| K130852 | Avance® Foam Abdominal Dressing KitOXJ · Traditional | 04/14/2014SE |
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| 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 |
| 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 |
| K031131 | Klinidrape Surgical DrapesKKX · Traditional | 06/10/2003SE |
Questions and answers
When was Mepilex Border AG Dressing cleared by the FDA?
Mepilex Border AG Dressing (K100029) received a 510(k) decision of Substantially Equivalent on September 15, 2010, 252 days after the submission was received.
What is the product code of K100029?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.