510(k) K060340
K060340 is an FDA 510(k) premarket notification submitted by Mpm Medical., Inc. for the device "ORAMAGIC PLUS ORAL WOUND RINSE". The FDA issued a decision of Substantially Equivalent on May 10, 2006. The device falls under product code OLR (Oral Wound Dressing), a Class U device. Mpm Medical., Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2006
- Date Received
- February 10, 2006
- 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.