The following data is part of a premarket notification filed by Novabay Pharmaceuticals with the FDA for Neutrophase Antimicrobial Wound Cleanser.
| Device ID | K113820 |
| 510k Number | K113820 |
| Device Name: | NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER |
| Classification | Dressing, Wound, Drug |
| Applicant | NOVABAY PHARMACEUTICALS 2081 LONGDEN CIRCLE Los Altos, CA 94024 |
| Contact | Sheila W Pickering |
| Correspondent | Sheila W Pickering NOVABAY PHARMACEUTICALS 2081 LONGDEN CIRCLE Los Altos, CA 94024 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-12-27 |
| Decision Date | 2012-08-08 |
| Summary: | summary |