The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Hypertonic Saline Wet Dressing - Sterile.
| Device ID | K941999 |
| 510k Number | K941999 |
| Device Name: | HYPERTONIC SALINE WET DRESSING - STERILE |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1994-06-29 |