The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set.
| Device ID | K160200 |
| 510k Number | K160200 |
| Device Name: | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set |
| Classification | Needle, Emergency Airway |
| 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 | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-28 |
| Decision Date | 2017-02-17 |
| Summary: | summary |