The following data is part of a premarket notification filed by Sopro-comeg Gmbh with the FDA for Ulyss Multi View Sinuscope.
| Device ID | K153701 |
| 510k Number | K153701 |
| Device Name: | ULYSS Multi View Sinuscope |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | SOPRO-COMEG GMBH DORNIERSTRASSE 55 Tuttlingen, DE 78532 |
| Contact | Harold Lettau |
| Correspondent | Angelika Scherp BUSINESS SUPPORT INTERNATIONAL AMSTEL 320-1 Amsterdam, NL 1017ap |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-09-09 |
| Summary: | summary |