The following data is part of a premarket notification filed by Aegis Surgical Ltd with the FDA for Illuminated Mediastinoscope.
| Device ID | K141622 |
| 510k Number | K141622 |
| Device Name: | ILLUMINATED MEDIASTINOSCOPE |
| Classification | Mediastinoscope, Surgical |
| Applicant | AEGIS SURGICAL LTD 113 GRANTWOOD DRIVE Holly Springs, NC 27540 |
| Contact | Tammy Carrea |
| Correspondent | Tammy Carrea AEGIS SURGICAL LTD 113 GRANTWOOD DRIVE Holly Springs, NC 27540 |
| Product Code | EWY |
| CFR Regulation Number | 874.4720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-17 |
| Decision Date | 2015-01-09 |
| Summary: | summary |