The following data is part of a premarket notification filed by Trigen Laboratories, Inc. with the FDA for Tl Triseb Cream.
| Device ID | K121134 |
| 510k Number | K121134 |
| Device Name: | TL TRISEB CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | TRIGEN LABORATORIES, INC. 11705 BOYETTE RD, STE 171 Riverview, FL 33569 |
| Contact | Melissa Goodhead |
| Correspondent | Melissa Goodhead TRIGEN LABORATORIES, INC. 11705 BOYETTE RD, STE 171 Riverview, FL 33569 |
| 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 | 2012-04-13 |
| Decision Date | 2012-07-25 |
| Summary: | summary |