510(k) K203091
K203091 is an FDA 510(k) premarket notification submitted by Pcca, Inc. for the device "MucoLock Oral Gel". The FDA issued a decision of Substantially Equivalent on February 12, 2021. The device falls under product code OLR (Oral Wound Dressing), a Class U device. Pcca, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2021
- Date Received
- October 13, 2020
- 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.