The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Saline Solution-sterile.
| Device ID | K933412 |
| 510k Number | K933412 |
| Device Name: | SALINE SOLUTION-STERILE |
| Classification | Tube Tracheostomy And Tube Cuff |
| 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 | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-13 |
| Decision Date | 1993-10-01 |