The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Melker Emergency Cricothyrotomy Catheter Set.
| Device ID | K013916 |
| 510k Number | K013916 |
| Device Name: | MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET |
| Classification | Needle, Emergency Airway |
| Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Heidi Masten |
| Correspondent | Heidi Masten COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-27 |
| Decision Date | 2001-12-20 |
| Summary: | summary |