The following data is part of a premarket notification filed by Tico Medical Instruments, Inc. with the FDA for T- Extension Set T-04-c.
| Device ID | K842985 |
| 510k Number | K842985 |
| Device Name: | T- EXTENSION SET T-04-C |
| Classification | Set, Administration, Intravascular |
| Applicant | TICO MEDICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1984-08-07 |