K050158 is an FDA 510(k) clearance for the SINCLAIR SEBORRHEA EMULSION, a Dressing, Wound, Drug, submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on October 11, 2006, 624 days after receiving the submission on January 25, 2005. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K050158 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 25, 2005 |
| Decision Date | October 11, 2006 |
| Days to Decision | 624 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |