The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Single Lumen Bronchial Tuvbe Set, Sterile, For Left & Right Sided Bronchial Intubation.
| Device ID | K953963 |
| 510k Number | K953963 |
| Device Name: | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION |
| Classification | Tube, Bronchial (w/wo Connector) |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | BTS |
| CFR Regulation Number | 868.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-11-27 |