The following data is part of a premarket notification filed by Polyganics Bv with the FDA for Nasopore-fd.
| Device ID | K141423 |
| 510k Number | K141423 |
| Device Name: | NASOPORE-FD |
| Classification | Splint, Intranasal Septal |
| Applicant | Polyganics BV ROZENBURGLAAN 15A Groningen, NL 9727-dl |
| Contact | Betty Ijmker |
| Correspondent | Betty Ijmker Polyganics BV ROZENBURGLAAN 15A Groningen, NL 9727-dl |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-30 |
| Decision Date | 2014-08-07 |
| Summary: | summary |