The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Weinmann Tracheostomy Exchange Set.
| Device ID | K180034 |
| 510k Number | K180034 |
| Device Name: | Weinmann Tracheostomy Exchange Set |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404 |
| Contact | Paul Meyer |
| Correspondent | Paul Meyer Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47404 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-04 |
| Decision Date | 2018-05-07 |
| Summary: | summary |