The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cook 810 Set, Desilets-hoffman Introducer Set.
| Device ID | K180028 |
| 510k Number | K180028 |
| Device Name: | Cook 810 Set, Desilets-Hoffman Introducer Set |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Carly Powell |
| Correspondent | Carly Powell Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-03 |
| Decision Date | 2018-05-02 |
| Summary: | summary |