Hydrofera Blue Pu Bacteriostatic Dressing
FDA 510(k) K130670 · Hydrofera, LLC
510(k) numberK130670
Submission
- Device name
- Hydrofera Blue Pu Bacteriostatic Dressing
- Applicant
- Hydrofera, LLC
Willimantic, CT, US - Received
- March 12, 2013
- Decision date
- January 2, 2014
- 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 |
|---|---|---|
| K190268 | Hydrofera Blue READY - BorderFRO · Traditional | 11/06/2019SE |
| 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 Pu Bacteriostatic Dressing cleared by the FDA?
Hydrofera Blue Pu Bacteriostatic Dressing (K130670) received a 510(k) decision of Substantially Equivalent on January 2, 2014, 296 days after the submission was received.
What is the product code of K130670?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.