The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Saline Wet Dressing- Sterile.
| Device ID | K934258 |
| 510k Number | K934258 |
| Device Name: | SALINE WET DRESSING- STERILE |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| 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 | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-31 |
| Decision Date | 1993-11-24 |