The following data is part of a premarket notification filed by Trigen Laboratories, Inc. with the FDA for Tl-cermide Skin Barrier Emulsion.
| Device ID | K110757 |
| 510k Number | K110757 |
| Device Name: | TL-CERMIDE SKIN BARRIER EMULSION |
| Classification | Dressing, Wound, Drug |
| Applicant | TRIGEN LABORATORIES, INC. 248 LATITUDE LANE SUITE 104 Lake Wylie, SC 29710 |
| Contact | George Mccauley |
| Correspondent | Loren Gelber TRIGEN LABORATORIES, INC. 54 Marina Rd SUITE 105 Lake Wylie, SC 29710 |
| 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 | 2011-03-18 |
| Decision Date | 2011-08-19 |
| Summary: | summary |