The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Reinforced Trachael Tube Cuffed, Sterile.
| Device ID | K955495 |
| 510k Number | K955495 |
| Device Name: | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE |
| Classification | Tube, Tracheal (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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-01 |
| Decision Date | 1996-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704005592 | K955495 | 000 |
| 24026704004687 | K955495 | 000 |
| 24026704004670 | K955495 | 000 |
| 24026704004663 | K955495 | 000 |
| 44026704004650 | K955495 | 000 |
| 24026704004649 | K955495 | 000 |
| 44026704004636 | K955495 | 000 |
| 44026704004629 | K955495 | 000 |
| 00850056748032 | K955495 | 000 |
| 44026704004698 | K955495 | 000 |
| 44026704004704 | K955495 | 000 |
| 44026704005589 | K955495 | 000 |
| 44026704005572 | K955495 | 000 |
| 24026704005561 | K955495 | 000 |
| 24026704005554 | K955495 | 000 |
| 44026704005541 | K955495 | 000 |
| 24026704005530 | K955495 | 000 |
| 44026704005527 | K955495 | 000 |
| 24026704005516 | K955495 | 000 |
| 00850056748025 | K955495 | 000 |