The following data is part of a premarket notification filed by Oculus Innovative Sciences, Inc. with the FDA for Oculus Microcyn Wound Gel.
Device ID | K090725 |
510k Number | K090725 |
Device Name: | OCULUS MICROCYN WOUND GEL |
Classification | Dressing, Wound, Drug |
Applicant | OCULUS INNOVATIVE SCIENCES, INC. 1135 N. MC DOWELL BLVD Petaluma, CA 94954 |
Contact | Antioinette Douglas |
Correspondent | Antioinette Douglas OCULUS INNOVATIVE SCIENCES, INC. 1135 N. MC DOWELL 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 | 2009-03-19 |
Decision Date | 2009-05-20 |
Summary: | summary |