K042722 is an FDA 510(k) clearance for the ALOCLAIR ORAL SPRAY. This device is classified as a Oral Wound Dressing.
Submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on January 13, 2005, 104 days after receiving the submission on October 1, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq..
| 510(k) Number | K042722 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 01, 2004 |
| Decision Date | January 13, 2005 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OLR — Oral Wound Dressing |
| Device Class | — |
| Definition | Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq. |