The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Rusch Easycric Emergency Cricothyrotomy Set.
| Device ID | K130405 |
| 510k Number | K130405 |
| Device Name: | RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET |
| Classification | Needle, Emergency Airway |
| Applicant | TELEFLEX MEDICAL 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl TELEFLEX MEDICAL 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-11-06 |
| Summary: | summary |