The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rush Oral/nasal Tracheal Tube Cuffed Magill/murphy.
| Device ID | K961837 | 
| 510k Number | K961837 | 
| Device Name: | RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY | 
| Classification | Tube, Tracheal (w/wo Connector) | 
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 | 
| Contact | Karenann J Brozowski | 
| Correspondent | Karenann J Brozowski RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 | 
| Product Code | BTR | 
| CFR Regulation Number | 868.5730 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1996-05-13 | 
| Decision Date | 1996-08-16 | 
| Summary: | summary |