510(k) K152055
K152055 is an FDA 510(k) premarket notification submitted by Oculus Innovative Sciences for the device "Ceramax Skin Barrier Cream". The FDA issued a decision of Substantially Equivalent on November 23, 2015. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Oculus Innovative Sciences has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2015
- Date Received
- July 24, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type