The following data is part of a premarket notification filed by Rebound Therapeutics with the FDA for Aurora Evacuator.
| Device ID | K180372 |
| 510k Number | K180372 |
| Device Name: | Aurora Evacuator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Rebound Therapeutics 13900 Alton Parkway, Suite 120 Irvine, CA 92618 |
| Contact | Jeffrey J. Valko |
| Correspondent | Jane Metcalf Rebound Therapeutics 13900 Alton Parkway, Suite 120 Irvine, CA 92618 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860624000431 | K180372 | 000 |
| 00860624000424 | K180372 | 000 |
| 00860624000417 | K180372 | 000 |
| 00850002332087 | K180372 | 000 |
| 00850002332070 | K180372 | 000 |
| 00850002332063 | K180372 | 000 |