The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Flexpointer 1.5 Mm.
| Device ID | K150473 |
| 510k Number | K150473 |
| Device Name: | FlexPointer 1.5 Mm |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | FIAGON GMBH NEUENDORFSTR. 23B Hennigsdorf, DE 16761 |
| Contact | Dr. Dirk Mucha |
| Correspondent | Dr. Dirk Mucha FIAGON GMBH NEUENDORFSTR. 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 | 2015-02-23 |
| Decision Date | 2015-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EFIAE0120041 | K150473 | 000 |