The following data is part of a premarket notification filed by Sonoma Pharmaceuticals, Inc. with the FDA for Microcyn Antimicrobial Hydrogel.
| Device ID | K173896 |
| 510k Number | K173896 |
| Device Name: | Microcyn Antimicrobial Hydrogel |
| Classification | Dressing, Wound, Drug |
| Applicant | Sonoma Pharmaceuticals, Inc. 1129 N. McDowell Blvd. Petaluma, CA 94954 |
| Contact | Brian Martin |
| Correspondent | Brian Martin Sonoma Pharmaceuticals, Inc. 1129 N. McDowell Blvd. Petaluma, CA 94954 |
| 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 | 2017-12-22 |
| Decision Date | 2018-04-02 |
| Summary: | summary |