The following data is part of a premarket notification filed by Rebound Therapeutics with the FDA for Aurora Evacuator.
| Device ID | K190075 |
| 510k Number | K190075 |
| Device Name: | Aurora Evacuator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Rebound Therapeutics 13900 Alton Parkway, Suite 120 Irvine, CA 92618 |
| Contact | Donald Atienza |
| Correspondent | Donald Atienza Rebound Therapeutics 13900 Alton Parkway, Suite 120 Irvine, CA 92618 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-16 |
| Decision Date | 2019-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002332025 | K190075 | 000 |
| 00850002332018 | K190075 | 000 |
| 00850002332001 | K190075 | 000 |
| 00850002332162 | K190075 | 000 |
| 00850002332155 | K190075 | 000 |
| 00850002332148 | K190075 | 000 |