The following data is part of a premarket notification filed by Rebound Therapeutics Corporation with the FDA for Aurora Surgiscope System.
| Device ID | K182211 |
| 510k Number | K182211 |
| Device Name: | Aurora Surgiscope System |
| Classification | Endoscope, Neurological |
| Applicant | Rebound Therapeutics Corporation 13900 Alton Parkway Irvine, CA 92618 |
| Contact | Jane Metcalf |
| Correspondent | Jane Metcalf Rebound Therapeutics Corporation 13900 Alton Parkway Irvine, CA 92618 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-15 |
| Decision Date | 2019-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860624000400 | K182211 | 000 |