K150914 is an FDA 510(k) clearance for the Dash-Topic Plus Cream. This device is classified as a Dressing, Wound, Drug.
Submitted by Founders Science Group, LLC (Cumberland, US). The FDA issued a Cleared decision on April 21, 2016, 381 days after receiving the submission on April 6, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K150914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2015 |
| Decision Date | April 21, 2016 |
| Days to Decision | 381 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |