The following data is part of a premarket notification filed by Polyganics Bv with the FDA for Nasopore Nasal Dressing, Model Ndox-yyy/zz.
| Device ID | K052099 |
| 510k Number | K052099 |
| Device Name: | NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ |
| Classification | Splint, Intranasal Septal |
| Applicant | Polyganics BV L.J. ZIELSTRAWEG 1 Groningen, NL 9713-gx |
| Contact | Jan Nieuwenhuis |
| Correspondent | Jan Nieuwenhuis Polyganics BV L.J. ZIELSTRAWEG 1 Groningen, NL 9713-gx |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-03 |
| Decision Date | 2005-11-21 |
| Summary: | summary |