The following data is part of a premarket notification filed by Global Health Solutions, Llc with the FDA for Hexagen Derm.
| Device ID | K171191 |
| 510k Number | K171191 |
| Device Name: | Hexagen Derm |
| Classification | Dressing, Wound, Drug |
| Applicant | Global Health Solutions, LLC 1360 Redmond Circle Rome, GA 30165 |
| Contact | Bradley Burnam |
| Correspondent | Bradley Burnam Global Health Solutions, LLC 1360 Redmond Circle Rome, GA 30165 |
| 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 | 2017-04-24 |
| Decision Date | 2017-08-25 |
| Summary: | summary |