The following data is part of a premarket notification filed by Novabay Pharmaceuticals with the FDA for Neutrophase.
| Device ID | K081009 |
| 510k Number | K081009 |
| Device Name: | NEUTROPHASE |
| Classification | Bandage, Liquid |
| Applicant | NOVABAY PHARMACEUTICALS 5980 HORTON ST. SUITE 550 Emeryville, CA 94608 |
| Contact | Sheila W Pickering |
| Correspondent | Sheila W Pickering NOVABAY PHARMACEUTICALS 5980 HORTON ST. SUITE 550 Emeryville, CA 94608 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-04-08 |
| Decision Date | 2008-05-20 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEUTROPHASE 77087100 3886559 Live/Registered |
Novabay Pharmaceuticals, Inc. 2007-01-19 |