The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Flexpointer 1.5 Single Use, Flextube 3 Single Use.
| Device ID | K200041 |
| 510k Number | K200041 |
| Device Name: | FlexPointer 1.5 Single Use, FlexTube 3 Single Use |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Fiagon GmbH Neuendorfstrasse 23b Hennigsdorf, DE 16761 |
| Contact | Dirk Mucha |
| Correspondent | Dirk Mucha Fiagon GmbH Neuendorfstrasse 23b Hennigsdorf, DE 16761 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-08 |
| Decision Date | 2020-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EFIAE0131042 | K200041 | 000 |
| EFIAE0130041 | K200041 | 000 |