The following data is part of a premarket notification filed by Oculus Innovative Sciences with the FDA for Ceramax Skin Barrier Cream.
| Device ID | K152055 |
| 510k Number | K152055 |
| Device Name: | Ceramax Skin Barrier Cream |
| Classification | Dressing, Wound, Drug |
| Applicant | OCULUS INNOVATIVE SCIENCES 1129 N. MCDOWELL BOULEVARD Petaluma, CA 94954 |
| Contact | Brian W. Martin |
| Correspondent | Brian W. Martin OCULUS INNOVATIVE SCIENCES 1129 N. MCDOWELL BOULEVARD 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 | 2015-07-24 |
| Decision Date | 2015-11-23 |
| Summary: | summary |