The following data is part of a premarket notification filed by Cook Incorporated with the FDA for 5.0 Fr Arndt Endobronchial Blocker Set.
| Device ID | K160542 |
| 510k Number | K160542 |
| Device Name: | 5.0 Fr Arndt Endobronchial Blocker Set |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Kotei Aoki |
| Correspondent | Kotei Aoki COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-26 |
| Decision Date | 2016-08-02 |
| Summary: | summary |