Copper Foam Dressing (Prescription and OTC)
FDA 510(k) K231088 · Roosin Medical Co., Ltd.
510(k) numberK231088
Submission
- Device name
- Copper Foam Dressing (Prescription and OTC)
- Applicant
- Roosin Medical Co., Ltd.
Taizhou, CN - Received
- April 17, 2023
- Decision date
- January 11, 2024
- 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 |
|---|---|---|
| K254034 | Roosin Collagen PowderKGN · Traditional | 06/03/2026SE |
| K253974 | Roosin Collagen DressingKGN · Traditional | 06/03/2026SE |
| K230190 | Polyver Silver Alginate Dressing (Prescription and OTC)FRO · Traditional | 11/17/2023SE |
| K181478 | Roosin Xeroform Petrolatum DressingFRO · Traditional | 09/13/2019SE |
Questions and answers
When was Copper Foam Dressing (Prescription and OTC) cleared by the FDA?
Copper Foam Dressing (Prescription and OTC) (K231088) received a 510(k) decision of Substantially Equivalent on January 11, 2024, 269 days after the submission was received.
What is the product code of K231088?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.