The following data is part of a premarket notification filed by Coria Laboratories, Ltd with the FDA for Tetrix Cream.
| Device ID | K071483 |
| 510k Number | K071483 |
| Device Name: | TETRIX CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | CORIA LABORATORIES, LTD 3909 HULEN ST Forth Worth, TX 76107 |
| Contact | Amy Campbell |
| Correspondent | Amy Campbell CORIA LABORATORIES, LTD 3909 HULEN ST Forth Worth, TX 76107 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-05-30 |
| Decision Date | 2008-04-04 |
| Summary: | summary |