The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Endotracheal Tube Stylet.
| Device ID | K952100 |
| 510k Number | K952100 |
| Device Name: | RUSCH ENDOTRACHEAL TUBE STYLET |
| Classification | Stylet, Tracheal Tube |
| 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 | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-04 |
| Decision Date | 1995-08-08 |