The following data is part of a premarket notification filed by Oculus Innovative Sciences with the FDA for Hydrocleanse Wound Care Solution.
Device ID | K141012 |
510k Number | K141012 |
Device Name: | HYDROCLEANSE WOUND CARE SOLUTION |
Classification | Dressing, Wound, Drug |
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 | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2014-04-21 |
Decision Date | 2014-08-08 |
Summary: | summary |