The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Pointershell Universal, Pointershell Ls.
| Device ID | K160479 |
| 510k Number | K160479 |
| Device Name: | PointerShell Universal, PointerShell LS |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | FIAGON GMBH NEUENDORFSTR. 23 B Hennigsdorf, DE 16761 |
| Contact | Dirk Mucha |
| Correspondent | Dirk Mucha FIAGON GMBH NEUENDORFSTR. 23 B 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 | 2016-02-22 |
| Decision Date | 2016-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EFIAE0129061 | K160479 | 000 |
| EFIAE0129041 | K160479 | 000 |
| 04260759930393 | K160479 | 000 |