The following data is part of a premarket notification filed by Boston-biomedical Associates with the FDA for Aegis Transit System.
| Device ID | K170757 |
| 510k Number | K170757 |
| Device Name: | Aegis Transit System |
| Classification | Mediastinoscope, Surgical |
| Applicant | Boston-Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, MA 01752 |
| Contact | Lauren Baker |
| Correspondent | Lauren Baker Boston-Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, MA 01752 |
| Product Code | EWY |
| CFR Regulation Number | 874.4720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-13 |
| Decision Date | 2017-07-14 |
| Summary: | summary |