The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Tracheofix-set.
| Device ID | K972423 |
| 510k Number | K972423 |
| Device Name: | RUSCH TRACHEOFIX-SET |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | James R Whitney |
| Correspondent | James R Whitney RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-27 |
| Decision Date | 1998-02-13 |
| Summary: | summary |