The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube - Uncuffed, Sterile.
| Device ID | K954585 |
| 510k Number | K954585 |
| Device Name: | RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong 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 | 1995-10-02 |
| Decision Date | 1996-05-10 |
| Summary: | summary |