The following data is part of a premarket notification filed by Oculus Innovative Sciences, Inc. with the FDA for Microcyn Skin And Wound Hydrogel.
| Device ID | K093585 |
| 510k Number | K093585 |
| Device Name: | MICROCYN SKIN AND WOUND HYDROGEL |
| Classification | Dressing, Wound, Drug |
| Applicant | OCULUS INNOVATIVE SCIENCES, INC. 1129 N. MCDOWELL BLVD. Petaluma, CA 94954 |
| Contact | Antoinette Douglas |
| Correspondent | Antoinette Douglas OCULUS INNOVATIVE SCIENCES, 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 | 2009-11-19 |
| Decision Date | 2010-03-08 |
| Summary: | summary |