The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Nasal Aspirator, Model, Ns1 Series.
| Device ID | K090379 |
| 510k Number | K090379 |
| Device Name: | AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | AVITA CORPORATION 2904 N. BOLDT DR. Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich AVITA CORPORATION 2904 N. BOLDT DR. Flagstaff, AZ 86001 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2010-05-26 |
| Summary: | summary |