The following data is part of a premarket notification filed by Rhinosystems, Inc. with the FDA for Navage Nasal Irrigator, Navage Nose Cleaner.
| Device ID | K140542 |
| 510k Number | K140542 |
| Device Name: | NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER |
| Classification | Irrigator, Powered Nasal |
| Applicant | RHINOSYSTEMS, INC. 5399 Lancaster Dr # 6 Brooklyn Heights, OH 44131 |
| Contact | Martin R Hoke |
| Correspondent | Martin R Hoke RHINOSYSTEMS, INC. 5399 Lancaster Dr # 6 Brooklyn Heights, OH 44131 |
| Product Code | KMA |
| CFR Regulation Number | 874.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-06-27 |
| Summary: | summary |