The following data is part of a premarket notification filed by Oculus Innovative Sciences, Inc. with the FDA for Dermacyn Wound Care.
Device ID | K060113 |
510k Number | K060113 |
Device Name: | DERMACYN WOUND CARE |
Classification | Dressing, Wound, Drug |
Applicant | OCULUS INNOVATIVE SCIENCES, INC. 1129 N. MCDOWELL BLVD. Petaluma, CA 94954 |
Contact | Tammy Atwood |
Correspondent | Tammy Atwood 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 | No |
Date Received | 2006-01-17 |
Decision Date | 2006-02-22 |
Summary: | summary |