The following data is part of a premarket notification filed by Rebound Therapeutics with the FDA for Aurora Evacuator +coag.
| Device ID | K201637 |
| 510k Number | K201637 |
| Device Name: | Aurora Evacuator +Coag |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Rebound Therapeutics 13900 Alton Parkway Suite 120 Irvine, CA 92618 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong 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 | 2020-06-16 |
| Decision Date | 2020-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002332223 | K201637 | 000 |
| 00850002332216 | K201637 | 000 |
| 00850002332209 | K201637 | 000 |