510(k) K090612
K090612 is an FDA 510(k) premarket notification submitted by Unicare Biomedical for the device "BENACEL". The FDA issued a decision of Substantially Equivalent on July 24, 2009. The device falls under product code OLR (Oral Wound Dressing), a Class U device. Unicare Biomedical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2009
- Date Received
- March 6, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oral Wound Dressing
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.