510(k) K183436
K183436 is an FDA 510(k) premarket notification submitted by Tbm Corporation for the device "OraCure". The FDA issued a decision of Substantially Equivalent on September 18, 2019. The device falls under product code OLR (Oral Wound Dressing), a Class U device. Tbm Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2019
- Date Received
- December 11, 2018
- 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.