The following data is part of a premarket notification filed by Carrington Laboratories, Inc. with the FDA for The Salicept Oral Patch.
| Device ID | K012126 |
| 510k Number | K012126 |
| Device Name: | THE SALICEPT ORAL PATCH |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | CARRINGTON LABORATORIES, INC. 2001 WALNUT HILL LN. Irving, TX 75038 |
| Contact | Kenneth M Yates |
| Correspondent | Kenneth M Yates CARRINGTON LABORATORIES, INC. 2001 WALNUT HILL LN. Irving, TX 75038 |
| 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 | 2001-07-06 |
| Decision Date | 2001-10-03 |
| Summary: | summary |