The following data is part of a premarket notification filed by Sinclair Pharmaceuticals, Ltd. with the FDA for Aloclair Oral Gel.
| Device ID | K040950 |
| 510k Number | K040950 |
| Device Name: | ALOCLAIR ORAL GEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | SINCLAIR PHARMACEUTICALS, LTD. 2340 TRINITY MILLS SUITE 300 Carrollton, TX 75006 |
| Contact | Michael Killeen |
| Correspondent | Michael Killeen SINCLAIR PHARMACEUTICALS, LTD. 2340 TRINITY MILLS SUITE 300 Carrollton, TX 75006 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-12 |
| Decision Date | 2004-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00358962301001 | K040950 | 000 |