The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Agt Pvc Pref Oral Trach Tube, Uncuf W/mur Ey.
| Device ID | K931166 |
| 510k Number | K931166 |
| Device Name: | RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Richard T Lykins |
| Correspondent | Richard T Lykins 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 | 1993-03-08 |
| Decision Date | 1993-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704063390 | K931166 | 000 |
| 24026704340440 | K931166 | 000 |
| 44026704340451 | K931166 | 000 |
| 44026704340468 | K931166 | 000 |
| 44026704340475 | K931166 | 000 |
| 24026704340488 | K931166 | 000 |
| 44026704340499 | K931166 | 000 |
| 24026704340501 | K931166 | 000 |
| 24026704340518 | K931166 | 000 |
| 24026704340433 | K931166 | 000 |