The following data is part of a premarket notification filed by Founders Science Group, Llc with the FDA for Dash-topic Plus Cream.
| Device ID | K150914 |
| 510k Number | K150914 |
| Device Name: | Dash-Topic Plus Cream |
| Classification | Dressing, Wound, Drug |
| Applicant | Founders Science Group, LLC 400 Highland Corporate Drive Cumberland, RI 02864 |
| Contact | Ronald M Gurge |
| Correspondent | Ronald M Gurge Founders Science Group, LLC 400 Highland Corporate Drive Cumberland, RI 02864 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-04-06 |
| Decision Date | 2016-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00372057001010 | K150914 | 000 |
| 00860003564905 | K150914 | 000 |
| 00383160001019 | K150914 | 000 |
| 00383160001002 | K150914 | 000 |
| 00383160000012 | K150914 | 000 |