The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Rusch Tracflex Plus Tracheostomy Tube Set.
| Device ID | K122235 |
| 510k Number | K122235 |
| Device Name: | RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-26 |
| Decision Date | 2013-09-06 |
| Summary: | summary |