The following data is part of a premarket notification filed by Advamedica Inc. with the FDA for Axiostat Patch.
| Device ID | K202830 |
| 510k Number | K202830 |
| Device Name: | Axiostat Patch |
| Classification | Dressing, Wound, Drug |
| Applicant | Advamedica Inc. Harvard Square, 1 Mifflin Place, Suite 400 Cambridge, MA 02138 |
| 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 | 2020-09-25 |
| Decision Date | 2021-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08600087686290 | K202830 | 000 |
| 00860008768629 | K202830 | 000 |
| 00860008768605 | K202830 | 000 |
| 00860008768681 | K202830 | 000 |