The following data is part of a premarket notification filed by Oculus Innovative Sciences with the FDA for Microcyn Scar Management Hydrogel.
| Device ID | K131672 |
| 510k Number | K131672 |
| Device Name: | MICROCYN SCAR MANAGEMENT HYDROGEL |
| Classification | Silicone Hydrogel For Scar Management |
| Applicant | OCULUS INNOVATIVE SCIENCES 1129 N MCDOWELL BLVD Petaluma, CA 94954 |
| Contact | Brian W Martin |
| Correspondent | Brian W Martin OCULUS INNOVATIVE SCIENCES 1129 N MCDOWELL BLVD Petaluma, CA 94954 |
| Product Code | PFP |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-06 |
| Decision Date | 2013-11-15 |
| Summary: | summary |