The following data is part of a premarket notification filed by Founders Science Group, Llc with the FDA for Hylaguard Moisturizing Cream.
| Device ID | K171879 |
| 510k Number | K171879 |
| Device Name: | HylaGuard Moisturizing Cream |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | Founders Science Group, LLC 30 Robert W. Boyden Road Suite A1000 Taunton, MA 02780 |
| Contact | Ronald M. Gurge |
| Correspondent | Ronald M. Gurge Founders Science Group, LLC 30 Robert W. Boyden Road Suite A1000 Taunton, MA 02780 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-06-23 |
| Decision Date | 2017-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383160000098 | K171879 | 000 |
| 00383160000029 | K171879 | 000 |