The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Fiagon Navigation System.
| Device ID | K162176 |
| 510k Number | K162176 |
| Device Name: | Fiagon Navigation System |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Fiagon GmbH Neuendorfstrasse 23b Hennigsdorf, DE 16761 |
| Contact | Dirk Mucha |
| Correspondent | Yarmela Pavlovic Hogan Lovells US LLP 3 Embarcadero Center, Suite 1500 San Francisco, CA 94111 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-03 |
| Decision Date | 2016-12-01 |
| Summary: | summary |