The following data is part of a premarket notification filed by Sioxmed, Llc. with the FDA for Sioxd Hemostatic Wound Matrix.
| Device ID | K222189 |
| 510k Number | K222189 |
| Device Name: | SiOxD Hemostatic Wound Matrix |
| Classification | Dressing, Wound, Drug |
| Applicant | SiOxMed, LLC. 2011 Muddy Creek Road Clemmons, NC 27012 |
| Contact | Mitch Dellinger |
| Correspondent | Linda Braddon Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-22 |
| Decision Date | 2022-11-18 |