K171879 is an FDA 510(k) clearance for the HylaGuard Moisturizing Cream, a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic, submitted by Founders Science Group, LLC (Taunton, US). The FDA issued a Cleared decision on October 16, 2017, 115 days after receiving the submission on June 23, 2017. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K171879 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 23, 2017 |
| Decision Date | October 16, 2017 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |