The following data is part of a premarket notification filed by Global Health Solutions, Llc with the FDA for Polyplex Wound Dressing.
| Device ID | K160872 |
| 510k Number | K160872 |
| Device Name: | PolyPlex Wound Dressing |
| 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 | 2016-03-30 |
| Decision Date | 2016-11-23 |
| Summary: | summary |