The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Dressing Change Tray Decubitus Ulcer/sterile-disp.
| Device ID | K921490 |
| 510k Number | K921490 |
| Device Name: | DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP |
| Classification | Wrap, Sterilization |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-30 |
| Decision Date | 1992-10-05 |