The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Fiagon Navigation – Pointertube Straight And Pointertube Keat.
| Device ID | K163416 |
| 510k Number | K163416 |
| Device Name: | Fiagon Navigation – PointerTube Straight And PointerTube Keat |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | FIAGON GMBH 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 | 2016-12-05 |
| Decision Date | 2017-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EFIAE0121081 | K163416 | 000 |
| EFIAE0121071 | K163416 | 000 |