The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Rusch Easy Tube.
| Device ID | K043205 |
| 510k Number | K043205 |
| Device Name: | RUSCH EASY TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | TELEFLEX MEDICAL 2345 WAUKEGAN ROAD Bannockburn, IL 60015 |
| Contact | Lori Hays |
| Correspondent | Lori Hays TELEFLEX MEDICAL 2345 WAUKEGAN ROAD Bannockburn, IL 60015 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-19 |
| Decision Date | 2005-01-07 |
| Summary: | summary |