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 |