MP 719
FDA 510(k) K070557 · Marine Polymer Technologies, Inc.
510(k) numberK070557
Submission
- Device name
- MP 719
- Applicant
- Marine Polymer Technologies, Inc.
Topsfield, MA, US - Received
- February 27, 2007
- Decision date
- May 23, 2007
- 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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| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K160695 | Talymed SuspensionFRO · Traditional | 12/06/2016SE |
| K132293 | Syvek Radial BandDXC · Traditional | 07/31/2014SE |
| K111524 | MP 719MTJ · Traditional | 07/22/2011SE |
| K102002 | TalymedFRO · Traditional | 07/28/2010SE |
| K082703 | MRDH BandageKMF · Traditional | 10/14/2008SE |
| K053300 | SyvekexcelDXC · Traditional | 03/28/2006SE |
| K002550 | RDH BandageKMF · Traditional | 12/20/2000SE |
| K984177 | Modification to SkvekpatchKMF · Traditional | 12/18/1998SN |
| K972914 | Syvek PatchKGX · Traditional | 12/22/1997SE |
Questions and answers
When was MP 719 cleared by the FDA?
MP 719 (K070557) received a 510(k) decision of Substantially Equivalent on May 23, 2007, 85 days after the submission was received.
What is the product code of K070557?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.