The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Sterile Water.
| Device ID | K933526 |
| 510k Number | K933526 |
| Device Name: | STERILE WATER |
| Classification | Catheter And Tip, Suction |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Contact | Partha Busumallik |
| Correspondent | Partha Busumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-21 |
| Decision Date | 1994-03-10 |