The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Agt Pvc Pref Nasal Trach Tub/uncuf W/mur Eye.
| Device ID | K931165 |
| 510k Number | K931165 |
| Device Name: | RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE |
| 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 |
|---|---|---|
| 24026704340594 | K931165 | 000 |
| 44026704340581 | K931165 | 000 |
| 24026704340570 | K931165 | 000 |
| 44026704340567 | K931165 | 000 |
| 44026704340550 | K931165 | 000 |
| 24026704340549 | K931165 | 000 |
| 44026704340536 | K931165 | 000 |
| 24026704340525 | K931165 | 000 |