The following data is part of a premarket notification filed by Oculus Innovative Sciences with the FDA for Loyon.
Device ID | K162217 |
510k Number | K162217 |
Device Name: | LOYON |
Classification | Dressing, Wound, Drug |
Applicant | Oculus Innovative Sciences 1129 N. McDowell Boulevard Petaluma, CA 94954 |
Contact | Brian W. Martin |
Correspondent | Brian W. Martin Oculus Innovative Sciences 1129 N. McDowell Boulevard 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 | 2016-08-08 |
Decision Date | 2017-03-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LOYON 79150153 4779464 Live/Registered |
Desmoid Aktiengesellschaft 2014-06-04 |