The following data is part of a premarket notification filed by Admedus Regen Pty Ltd with the FDA for Adapt Tissue.
| Device ID | K200566 |
| 510k Number | K200566 |
| Device Name: | ADAPT Tissue |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | Admedus Regen Pty Ltd 26 Harris Road Malaga, AU 6080 |
| Contact | Kiran Bhirangi |
| Correspondent | Diana Upp Admedus Regen Pty Ltd 860 Blue Gentian Road, Suite 340 Eagan, MN 55121 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-04 |
| Decision Date | 2020-04-03 |