The following data is part of a premarket notification filed by Polyganics Bv with the FDA for Nasopore Ear.
| Device ID | K070715 |
| 510k Number | K070715 |
| Device Name: | NASOPORE EAR |
| Classification | Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| 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 | NHB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-14 |
| Decision Date | 2007-05-07 |
| Summary: | summary |