The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Central Venous Catheter, Dressing Change Kit, Ster.
| Device ID | K920846 |
| 510k Number | K920846 |
| Device Name: | CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER |
| Classification | Mask, Surgical |
| 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 | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-25 |
| Decision Date | 1992-09-01 |