The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Tracheofix Set, Cuffed And Uncuffed.
| Device ID | K021764 |
| 510k Number | K021764 |
| Device Name: | RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Rick Lykins |
| Correspondent | Rick Lykins RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-29 |
| Decision Date | 2002-07-23 |
| Summary: | summary |