The following data is part of a premarket notification filed by Novabay Pharmaceuticals, Inc with the FDA for Neutrophase(r) Skin And Wound Cleanser Otc.
| Device ID | K131542 |
| 510k Number | K131542 |
| Device Name: | NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC |
| Classification | Dressing, Wound, Drug |
| Applicant | Novabay Pharmaceuticals, Inc 5600 WISCONSIN AVENUE # 509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler Novabay Pharmaceuticals, Inc 5600 WISCONSIN AVENUE # 509 Chevy Chase, MD 20815 |
| 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 | 2013-05-29 |
| Decision Date | 2013-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857005004232 | K131542 | 000 |