The following data is part of a premarket notification filed by Oculus Innovative Sciences, Inc. with the FDA for Microcyn Wound Care Dressing.
Device ID | K041161 |
510k Number | K041161 |
Device Name: | MICROCYN WOUND CARE DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | OCULUS INNOVATIVE SCIENCES, INC. 1129 N. MCDOWELL BLVD. Petaluma, CA 94954 |
Contact | Manisha S Deshmukh |
Correspondent | Manisha S Deshmukh 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 | 2004-05-03 |
Decision Date | 2005-05-03 |
Summary: | summary |