The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Cat.#40100, 40102, 40104 & 40106 Yankauer Suct Int.
| Device ID | K921464 |
| 510k Number | K921464 |
| Device Name: | CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT |
| Classification | Catheter, Continuous Irrigation |
| 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 | GBQ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-27 |
| Decision Date | 1992-05-05 |