K013056 is an FDA 510(k) clearance for the GELCLAIR CONCENTRATED ORAL GEL. This device is classified as a Oral Wound Dressing.
Submitted by Sinclair Pharmaceuticals, Ltd. (Chinley, High Peak, GB). The FDA issued a Cleared decision on December 21, 2001, 101 days after receiving the submission on September 11, 2001.
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 | K013056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2001 |
| Decision Date | December 21, 2001 |
| Days to Decision | 101 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. |