The following data is part of a premarket notification filed by Novabay Pharmaceuticals with the FDA for Neutrophase Wound Cleanser.
| Device ID | K071056 |
| 510k Number | K071056 |
| Device Name: | NEUTROPHASE WOUND CLEANSER |
| Classification | Dressing, Wound, Drug |
| Applicant | NOVABAY PHARMACEUTICALS 5080 HORTON STREET SUITE 550 Emeryville, CA 94608 |
| Contact | Luana Staiger |
| Correspondent | Luana Staiger NOVABAY PHARMACEUTICALS 5080 HORTON STREET SUITE 550 Emeryville, CA 94608 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-09-28 |
| Summary: | summary |