The following data is part of a premarket notification filed by Polyganics Bv with the FDA for Nasopore Ear, Models Nd04, Nd05.
| Device ID | K062540 |
| 510k Number | K062540 |
| Device Name: | NASOPORE EAR, MODELS ND04, ND05 |
| Classification | Ear Wick |
| 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 | KCN |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2006-10-18 |
| Summary: | summary |