The following data is part of a premarket notification filed by Sinclair Pharmaceuticals, Ltd. with the FDA for Sinclair Seborrhea Emulsion.
| Device ID | K050158 |
| 510k Number | K050158 |
| Device Name: | SINCLAIR SEBORRHEA EMULSION |
| Classification | Dressing, Wound, Drug |
| Applicant | SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. Godalming, Surrey, GB Gu7 2ab |
| Contact | Micheal Killeen |
| Correspondent | Micheal Killeen SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. Godalming, Surrey, GB Gu7 2ab |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-01-25 |
| Decision Date | 2006-10-11 |
| Summary: | summary |