510(k) K070842
K070842 is an FDA 510(k) premarket notification submitted by Sunshine International Group, Inc. for the device "ULCELOOCIN ORAL ULCER PATCH". The FDA issued a decision of Substantially Equivalent on Jun 7, 2007. The device falls under product code OLR (Oral Wound Dressing), a Class U device.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 7, 2007
- Date Received
- Mar 27, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Oral Wound Dressing
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.