The following data is part of a premarket notification filed by Advamedica Inc. with the FDA for Axiostat Chitosan Hemostatic Dressing.
| Device ID | K172324 |
| 510k Number | K172324 |
| Device Name: | Axiostat Chitosan Hemostatic Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Advamedica Inc. 485 Massachusetts Avenue, Suite 300, Cambridge, MA 02139 |
| Contact | Leo Mavely |
| Correspondent | Alan Donald Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, CA 92108 |
| 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 | 2017-08-01 |
| Decision Date | 2018-02-23 |
| Summary: | summary |