Hydrofera Blue READY - Border
FDA 510(k) K190268 · Hydrofera, LLC
510(k) numberK190268
Submission
- Device name
- Hydrofera Blue READY - Border
- Applicant
- Hydrofera, LLC
Manchester, CT, US - Received
- February 8, 2019
- Decision date
- November 6, 2019
- 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 |
|---|---|---|
| K130670 | Hydrofera Blue Pu Bacteriostatic DressingFRO · Traditional | 01/02/2014SE |
| K023138 | Hydrofera Bacteriostatic Wound DressingFRO · Traditional | 01/17/2003SE |
| K013462 | Hydrofera Bacteriostatic Wound DressingFRO · Traditional | 01/11/2002SE |
| K983276 | Hydrofera Bacteristatic Nasal DressingEMX · Traditional | 09/14/1999SE |
| K974313 | Hydrofera Surgical SpearHOZ · Traditional | 03/02/1998SE |
| K974316 | Hydrofera Femoral WickEFQ · Traditional | 02/13/1998SE |
Questions and answers
When was Hydrofera Blue READY - Border cleared by the FDA?
Hydrofera Blue READY - Border (K190268) received a 510(k) decision of Substantially Equivalent on November 6, 2019, 271 days after the submission was received.
What is the product code of K190268?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.