The following data is part of a premarket notification filed by Sinclair Pharmaceuticals, Ltd. with the FDA for Gelclair Concentrated Oral Gel.
| Device ID | K013056 |
| 510k Number | K013056 |
| Device Name: | GELCLAIR CONCENTRATED ORAL GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | SINCLAIR PHARMACEUTICALS, LTD. 1 ALDER BROOK Chinley, High Peak, GB Sk23 6dn |
| Contact | Priscilla Cox |
| Correspondent | Priscilla Cox SINCLAIR PHARMACEUTICALS, LTD. 1 ALDER BROOK Chinley, High Peak, GB Sk23 6dn |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-11 |
| Decision Date | 2001-12-21 |
| Summary: | summary |